GlobeNewswire by notified

Idorsia receives US FDA approval of QUVIVIQ (daridorexant) 25 and 50 mg for the treatment of adults with insomnia

Share

Ad hoc announcement pursuant to Art. 53 LR

Idorsia receives US FDA approval of QUVIVIQ (daridorexant) 25 and 50 mg for the treatment of adults with insomnia

  • The approval of QUVIVIQ™ – 25 & 50 mg – is based on a robust Phase 3 clinical program that demonstrated significant improvement versus placebo on objective measures of sleep onset and sleep maintenance, as well as patient reported total sleep time
  • Idorsia’s first approved medicine is a new treatment option for the approximately 25 million American adults living with insomnia2,3,4

Allschwil, SwitzerlandJanuary10, 2022
Idorsia Ltd (SIX: IDIA) today announced that the US Food and Drug Administration (FDA) has approved QUVIVIQ™ (daridorexant) 25 mg and 50 mg for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance1. The FDA approval of QUVIVIQ is based on an extensive clinical program that included 1,854 adults with insomnia at over 160 clinical trial sites across 18 countries. Insomnia, a serious medical condition, is the most common sleep disorder in the US.

QUVIVIQ is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain.

During the Phase 3 clinical program, QUVIVIQ demonstrated significant improvement versus placebo on objective measures of sleep onset and sleep maintenance, and patient reported total sleep time. Consistent with the US prescribing information, the 50 mg dose of QUVIVIQ, which was evaluated in one of the two pivotal studies, demonstrated a significant reduction in patient reported daytime sleepiness, using a validated instrument. The most common adverse reactions (in at least 5% of patients and greater than placebo) were headache (placebo: 5%, 25 mg: 6%, 50 mg: 7%,) and somnolence or fatigue (placebo: 4%, 25 mg: 6%, 50 mg: 5%).

The FDA has recommended that QUVIVIQ be classified as a controlled substance and it is anticipated to be available to patients in May 2022, following scheduling by the US Drug Enforcement Administration.

Martine Clozel, MD and Chief Scientific Officer of Idorsia, commented:
“After more than 20 years of research and a progressive understanding of the role of orexin in sleep-wake balance and of the potential of orexin receptor antagonism, we designed daridorexant to help address several issues people with insomnia face. Daridorexant properties include a potent inhibition of both orexin receptors, a rapid absorption for sleep onset, and a pharmacokinetic profile such that around 80% of daridorexant has been eliminated after a night of sleep to help minimize residual effects.”

Dr Thomas Roth, PhD, Director of the Sleep Disorder and Research Center at Henry Ford Hospital, commented:
“As noted in the definition of insomnia, the disorder is not only a problem of the night but affects a patient’s ability to function during the day. Although the personal and societal burden of insomnia is well established, elevating the impact insomnia has on both the night and day remains critical in addressing patients’ needs. I am encouraged to see a new advanced treatment option for the millions of adults struggling with insomnia.”

Patricia Torr, President and General Manager of Idorsia US added:
“I am extremely proud to be leading the US organization of such a forward-thinking and patient-centric organization like Idorsia. With this first FDA approval for our company, QUVIVIQ provides a new treatment option that can help adults with insomnia get to sleep faster and stay asleep longer, which we know plays an important role in how they feel the next day. It’s an incredibly exciting time for us and I can’t wait to transform the treatment paradigm in the US. We have a differentiated product, an amazing team, and an innovative strategy, giving me absolute confidence that we can make QUVIVIQ a great success.”

Guy Braunstein, MD and Head of Global Clinical Development of Idorsia, commented:
“In our investigation of daridorexant we were able to demonstrate an improvement on objective sleep parameters, as well as improvement in patient-reported outcomes. What is truly impressive, we have shown a dose response in the efficacy of daridorexant, with no increase in the rate of somnolence or fatigue with increasing doses.”

Phase 3 Clinical Program
The efficacy of QUVIVIQ was evaluated in two multicenter, randomized, double-blind, placebo-controlled, parallel-group studies, Study 1 (NCT03545191) and Study 2 (NCT03575104).

A total of 1854 patients with Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5®) insomnia were randomized to receive QUVIVIQ or placebo once daily, in the evening, for 3 months. Study 1 randomized 930 subjects to QUVIVIQ 50 mg (N = 310), 25 mg (N = 310) or placebo (N = 310). Study 2 randomized 924 subjects to QUVIVIQ 25 mg (N = 309), 10 mg (N = 307), or placebo (N = 308). The 10 mg dose is not an approved dose.

At the end of the 3-month treatment period, both studies included a 7-day placebo run-out period, after which patients could enter a 9-month, double-blind, placebo-controlled extension study (Study 3, NCT03679884). A total of 600 subjects were treated for at least 6 months of cumulative treatment, including 373 treated for at least 12 months.

Primary efficacy endpoints for both studies were the change from baseline to Month 1 and Month 3 in Latency to Persistent Sleep (LPS) and Wake After Sleep Onset (WASO), measured objectively by polysomnography in a sleep laboratory. LPS is a measure of sleep induction and WASO is a measure of sleep maintenance.

Secondary endpoints included in the statistical testing hierarchy with Type I error control were patient-reported Total Sleep Time (sTST), evaluated every morning at home using a validated Sleep Diary Questionnaire (SDQ).

In Study 1, doses of 25 and 50 mg QUVIVIQ showed a statistically significant improvement vs placebo on polysomnography (LPS, WASO) and self-reported total sleep (sTST), at Month 1 and Month 3.

In Study 2, QUVIVIQ 25 mg showed a statistically significant improvement vs placebo on WASO and sTST at Month 1 and Month 3. QUVIVIQ 10 mg did not show a statistically significant improvement on LPS, WASO, or sTST at Month 1 or Month 3.

The efficacy of QUVIVIQ was similar across subgroups based on age, sex, race, and region.

The 50 mg dose of QUVIVIQ, which was evaluated in one of the two pivotal studies, also demonstrated significant reduction in daytime sleepiness compared to placebo, as measured by the sleepiness domain score from the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ)7 at month 1 and month 3 (key secondary endpoint). Results on this endpoint for the 25mg dose did not reach statistical significance in either study at both timepoints.

The most common reported adverse reactions (in at least 5% of patients and greater than placebo) were headache (placebo: 5%, 25 mg: 6%, 50 mg: 7%,) and somnolence or fatigue (placebo: 4%, 25 mg: 6%, 50 mg: 5%).

For more information see the Full Prescribing Information (PI and Medication Guide).

Important Safety Information

QUVIVIQ is a prescription medicine for adults who have trouble falling asleep or staying asleep (insomnia).

Do nottake QUVIVIQ if you fall asleep often at unexpected times (narcolepsy).

QUVIVIQ may cause serious side effects, including:

  • Decreased awareness and alertness. The morning after you take QUVIVIQ, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day.
    • Do not take more QUVIVIQ than prescribed.
    • Do not take QUVIVIQ unless you are able to stay in bed for at least 7 hours before you must be active again.
    • Take QUVIVIQ at night within 30 minutes before going to bed.

QUVIVIQ is a federally controlled substance because it can be abused or lead to dependence.

Before taking QUVIVIQ, tell your healthcare provider about all of your medical conditions, including if you:

  • have a history of depression, mental illness, or suicidal thoughts or actions; drug or alcohol abuse or addiction; a sudden onset of muscle weakness (cataplexy); daytime sleepiness
  • have lung or breathing problems, including sleep apnea
  • have liver problems
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements

  • Taking QUVIVIQ with certain medicines can cause serious side effects. QUVIVIQ may affect the way other medicines work and other medicines may affect the way QUVIVIQ works.
  • Do not take QUVIVIQ with other medicines that can make you sleepy unless instructed by your healthcare provider.

What should I avoid while taking QUVIVIQ?

  • Do not drink alcohol while taking QUVIVIQ. It can increase the effects of alcohol, which can be dangerous.
  • Do not drive, operate heavy machinery, do anything dangerous, or do other activities that require clear thinking if you do not feel fully awake, or you have taken QUVIVIQ and have less than a full night of sleep (at least 7 hours), or if you have taken more QUVIVIQ than prescribed.

QUVIVIQ may cause other serious side effects, including:

  • Worsening depression and suicidal thoughts. Call your healthcare provider right away if you have any worsening depression or thoughts of suicide or dying.
  • Temporary inability to move or talk (sleep paralysis) for up to several minutes, or hallucinations while you are going to sleep or waking up.
  • Complex sleep behaviors such as sleep-walking, sleep-driving, preparing and eating food, making phone calls, having sex or doing other activities while not fully awake that you may not remember the next morning. Stop taking QUVIVIQ and call your healthcare provider right away if you experience a complex sleep behavior.

The most common side effects of QUVIVIQ are headache and sleepiness.

These are not the only side effects of QUVIVIQ. Call your doctor for advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Notes to the editor

About Insomnia
According to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5®), insomnia is defined as a combination of difficulty obtaining sufficient sleep and dissatisfaction with sleep combined with a significant negative impact on daytime functioning. Chronic insomnia is defined as difficulty initiating and/or maintaining sleep on at least three nights per week for at least three months, despite adequate opportunity to sleep.

Insomnia is a condition of overactive brain activity during sleep, and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia.

Insomnia is the most common sleep disorder, affecting more than 25 million adults in the US.2 Poor quality or insufficient sleep can affect many aspects of the daily lives of people with trouble sleeping including the ability to concentrate, mood and energy levels.3 In the long-term, insomnia is associated with numerous serious health conditions, such as psychiatric disorders, cardiovascular disease, type 2 diabetes, substance abuse and dementia.4,5,6

About Dr. Thomas Roth, PhD
Dr. Roth has been the Director of the Sleep Disorders and Research Center at Henry Ford Hospital in Detroit, since 1978. Dr. Roth is also a Professor in the Department of Psychiatry at Wayne State University, School of Medicine in Detroit, Michigan, and serves as a Clinical Professor in the Department of Psychiatry at the University of Michigan, College of Medicine in Ann Arbor.

After serving as president of the Sleep Research Society, and the founding president of the National Sleep Foundation (NSF), Dr. Roth became chairman of the National Center on Sleep Disorders Research advisory board. In addition, he was a member of the board of directors of the Associated Professional Sleep Societies (APSS), chaired the Association's Scientific Program Committee and the governing board of the World Federation of Sleep Research Societies.

Dr. Roth was instrumental in the formation of the Association of Sleep Disorders Center (ASDC) and served as the organization's second president. He is also the former Chairman of the World Health Organization's worldwide project on sleep and health. In addition to authoring and co-authoring numerous articles, Dr. Roth serves as past editor-in-chief of the journal Sleep. He currently sits on the editorial boards of Sleep Reviews, Stress Medicine, and Advances in Therapy and Human Psychopharmacology.

In 2002, Dr. Roth received the NSF's Lifetime Achievement Award for his accomplishments and contributions to sleep science, sleep medicine and public health. He received a Distinguished Research Award from the Sleep Research Society as well as the Nathanial Kleitman Award from the Academy of Sleep Medicine. Dr. Roth's contributions to the sleep field are expansive, ranging from prolific research productivity and scholarship to multiple national leadership positions, as well as the mentoring of many students and colleagues. Dr. Roth serves as a consultant to Idorsia.

References

  1. QUVIVIQ Prescribing Information. Idorsia Pharmaceuticals US Inc. Jan/2022
  2. Bhaskar S, Hemavathy D, Prasad S. Prevalence of chronic insomnia in adult patients and its correlation with medical comorbidities. J Family Med Prim Care. 2016;5(4):780-784. doi:10.4103/2249-4863.201153.
  3. Ustinov Y, Lichstein KL, Wal GS, Taylor DJ, Riedel BW, Bush AJ. Association between report of insomnia and daytime functioning. Sleep Med. 2010 Jan;11(1):65-8. doi: 10.1016/j.sleep.2009.07.009. Epub 2009 Sep 23.
  4. Olfson M, Wall M, Liu SM, Morin CM, Blanco C. Insomnia and Impaired Quality of Life in the United States. J Clin Psychiatry. 2018 Sep 11;79(5):17m12020. doi: 10.4088/JCP.17m12020.
  5. Doghramji K. The epidemiology and diagnosis of insomnia. Am J Manag Care. 2006 May;12(8 Suppl): S214-20. PMID: 16686591.
  6. de Almondes KM, Costa MV, Malloy-Diniz LF, Diniz BS. Insomnia and risk of dementia in older adults: Systematic review and meta-analysis. J Psychiatr Res. 2016 Jun;77:109-15. doi: 10.1016/j.jpsychires.2016.02.021. Epub 2016 Mar 8. PMID: 27017287.
  7. Hudgens S, Phillips-Beyer A, Newton L, Seboek Kinter D, Benes H. Development and validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). Patient. 2020;14(2): 249-268. https://doi. org/ 10. 1007/ s40271- 020- 00474-z

About Idorsia US
Idorsia US, an affiliate of Idorsia, is reaching out for more – we have more ideas, we see more opportunities, and we want to help more patients. To achieve this, we will help develop Idorsia into a leading biopharmaceutical company, with a strong scientific core. With commercial operations based outside of Philadelphia, PA, one of densest communities of life sciences talent in the world, we are helping to realize the company’s ambition of bringing innovative medicines from bench to bedside. Our goal is to build a commercial footprint that will deliver Idorsia’s deep pipeline of products from its R&D engine to the US market – with the potential to change the lives of many patients.

About Idorsia
Idorsia Ltd is reaching out for more – We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.

Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, state-of-the-art facilities, and a strong balance sheet – the ideal constellation to translate R&D efforts into business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1’000 highly qualified specialists dedicated to realizing our ambitious targets.

For further information, please contact
US Media
Christopher Clark
Senior Director, US Head of Communications
Idorsia Pharmaceuticals US, 100 Matsonford Road, Radnor, PA 19087
+1 (215) 421 4887
christopher.clark@idorsia.com
www.idorsia.us

Global Investors & Media
Andrew C. Weiss
Senior Vice President, Head of Investor Relations & Corporate Communications
Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil
+41 58 844 10 10
investor.relations@idorsia.com
media.relations@idorsia.com
www.idorsia.com

The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.


Attachment

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

Stevie® Awards Announce Winners in 19th Annual International Business Awards® from Across the Globe15.8.2022 13:00:00 CEST | Press release

3,700 Nominations Were Submitted from Organizations in 67 Nations FAIRFAX, Va., Aug. 15, 2022 (GLOBE NEWSWIRE) -- High-achieving organizations and executives around the world have been recognized as Gold, Silver, and Bronze Stevie® Award winners in The 19th Annual International Business Awards®, the world's only international, all-encompassing business awards program. Winners were selected from more than 3,700 nominations submitted by organizations in 67 nations. A complete list of all 2022 Gold, Silver and Bronze Stevie Award winners by category is available at www.StevieAwards.com/IBA. More than 300 executives worldwide participated on 11 juries to determine the Stevie winners. The top winner of Gold, Silver, and Bronze Stevie Awards is HALKBANK of Istanbul, Turkey with 32. Other winners of multiple Stevie Awards include IBM Corporation (21), LLYC (20), Deutsche Post DHL (19), Abu Dhabi Ports Group (17), Viettel Group (17), OPET (15), Telkom Indonesia (13), ZER (13), Ayala Land Inc.

Bergman & Beving acquires Polartherm15.8.2022 13:00:00 CEST | Press release

Press release Bergman & Beving acquires Polartherm Bergman & Beving has today acquired 80 per cent of the shares in Polartherm Group. Polartherm is a leading player within powerful, mobile heaters for certain niches within industry, construction and aviation. Polartherm has an annual revenue of approximately MEUR 12 with good profitability. The business is based in Luvia and Kokemäki in Finland and has 57 employees. ”Polartherm has a market leading position within mobile heaters with impressive customer base within inter alia the aviation and defence sectors around the world. Our ambition with the company is now to further enhance the growth journey which the company’s management has already initiated”, says Oscar Fredell, Head of Division Tools & Consumables. “We are looking forward to joining Bergman&BevingGroup. Due to its long-term and stable position we consider it a suitable majority owner for Polartherm going forward”, says the managing director and part-owner Pasi Anttila who w

Bergman & Beving förvärvar Polartherm15.8.2022 13:00:00 CEST | Pressemelding

Pressmeddelande Bergman & Beving förvärvar Polartherm Bergman & Beving har idag förvärvat 80 procent av aktierna i Polartherm Group. Polartherm är en ledande aktör inom kraftfulla, mobila värmeaggregat för nischområden inom industri-, bygg- och flygbranscherna. Polartherm omsätter cirka 12 MEUR per år med god lönsamhet. Verksamheten är baserad i Luvia och Kokemäki i Finland och har 57 anställda. ”Polartherm har en marknadsledande position inom mobila värmeaggregat med en imponerande kundbas inom bl.a. flyg- och försvarssektorerna runtom i världen. Vårt mål med bolaget blir nu att förstärka den tillväxtresa som bolagets ledning redan påbörjat”, säger Oscar Fredell, divisionschef Tools & Consumables. ”Vi ser fram emot att bli en del av Bergman&Bevingkoncernen. Med sin långsiktiga och stabila position ser vi dem som en lämplig huvudägare för Polartherm framåt”, säger VD:n och delägaren Pasi Anttila, som fortsätter som VD och minoritetsägare i bolaget. Polartherm kommer att ingå i division

Nordic American Tankers Ltd (NYSE: NAT) – Update on contracts15.8.2022 12:36:19 CEST | Press release

Monday, August 15, 2022 Dear Shareholders and Investors, Below are the latest contracts for our suezmax ships, showing the level of the market. The rates we experience now are far above recent quarters. 12th Aug.: Vessel fixed on subjects to US Oil Major for voyage from Mediterranean to Asia. Time Charter Equivalent (TCE) about USD 60,000 over 35 days 12th Aug.: Vessel fixed on subjects to Asian interests for voyage from AG to Singapore. Time Charter Equivalent (TCE) about USD 19,000 over 36 days 4th Aug.: Vessel fixed to Asian interests for voyage cross Mediterranean. Time Charter Equivalent (TCE) about USD 40,000 over 15 days 3rd Aug.: Vessel fixed to Asian interests for voyage from Red Sea to Asia. Time Charter Equivalent (TCE) about USD 21,500 over 45 days 28th July: Vessel fixed to Asian interests for voyage from AG to Singapore. Time Charter Equivalent (TCE) about USD 46,500 over 26 days 25th July: Vessel fixed to American interests for voyage (positioning voyage) from AG to US G