Business Wire

Incyte Announces Acceptance and Priority Review of NDA for Ruxolitinib Cream for Atopic Dermatitis

Share

Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for ruxolitinib cream, a selective JAK1/JAK2 inhibitor designed for topical application, as a treatment for atopic dermatitis (AD), a type of eczema.

“Incyte’s deep understanding of the pathways involved in immune-mediated skin conditions led us to investigate the potential for ruxolitinib cream to address key factors associated with atopic dermatitis, that is, inflammation of the skin and itch,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “We are grateful to the people living with atopic dermatitis whose participation in our clinical trials helped generate the evidence to support this regulatory submission, and we look forward to working with the FDA as we seek to bring forward a new topical treatment for people living with this chronic skin disease.”

The NDA is supported by data from the Phase 3 TRuE-AD clinical trial program, which included more than 1,200 people, age 12 years and older. Primary efficacy and safety results from both TRuE-AD trials were presented at the Revolutionizing Atopic Dermatitis Virtual Symposium in April 2020. Additional safety and efficacy data from the 44-week, open-label, long-term extension of both TRuE-AD1 and TRuE-AD2 were included in the NDA.

Incyte submitted a priority review voucher (PRV) along with the NDA application for ruxolitinib cream. The use of the PRV shortens the review period by four months. The Prescription Drug User Fee Act (PDUFA) target action date is June 21, 2021.

About Atopic Dermatitis
Atopic dermatitis (AD) is a chronic skin disease, affecting more than 21 million people in the United States and is characterized by inflammation and intense itch. Signs and symptoms of AD include irritated and itchy skin that can cause red lesions that may ooze and crust. Patients with AD are also more susceptible to bacterial, viral and fungal infections.

About TRuE-AD
The TRuE-AD clinical trial program consists of two randomized, double-blind, vehicle-controlled Phase 3 studies, TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651), evaluating the safety and efficacy of ruxolitinib cream compared to vehicle (non-medicated cream) in patients with atopic dermatitis (AD). Both studies enrolled more than 600 patients (age ≥12 years) diagnosed with AD for at least two years and who were candidates for topical therapy.

Patients with an Investigator’s Global Assessment (IGA) score of 2 to 3, and with AD on 3% to 20% of their Body Surface Area (excluding scalp) were randomized 2:2:1 into one of three arms for eight weeks: ruxolitinib cream 0.75% applied twice daily (BID); ruxolitinib cream 1.5% applied BID; and vehicle. Participants who successfully completed an assessment at Week 8 were offered participation in the 44-week long-term safety treatment extension period with ruxolitinib cream 0.75% or 1.5% applied BID.

The primary endpoint of the TRuE-AD studies was the proportion of participants achieving an Investigator’s Global Assessment Treatment Success (IGA-TS), defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline at Week 8. Key secondary endpoints include: the proportion of patients achieving at least a 75% improvement from baseline in the Eczema Area and Severity Index (EASI-75) score, the proportion of participants with at least a 4-point improvement in the itch Numerical Rating Scale, and the proportion of participants with at least a 6-point improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form – Sleep Disturbance (8b) 24-hour recall score. Additional secondary endpoints include mean percentage change from baseline in Scoring Atopic Dermatitis (SCORAD) score. The studies have also been tracking the frequency, duration and severity of adverse events associated with the use of ruxolitinib cream.

TRuE-AD results presented at the 29th European Academy of Dermatology and Venereology (EADV) Congress in October 2020 examined sleep quality, sleep depth and restoration associated with sleep, key quality of life measures for people with AD.

For more information about the TRuE-AD studies, please visit http://clinicaltrials.gov/ct2/show/NCT03745638 and http://clinicaltrials.gov/ct2/show/NCT03745651.

About Ruxolitinib Cream
Ruxolitinib cream is a proprietary formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application. Ruxolitinib cream is currently in Phase 3 development for the treatment of atopic dermatitis (TRuE-AD) and for the treatment of adolescents and adults with vitiligo (TRuE-V). Incyte has worldwide rights for the development and commercialization of ruxolitinib cream.

About Incyte Dermatology
Incyte’s science-first approach and expertise in immunology has formed the foundation of the company. In Dermatology, the Company’s research and development efforts are focused on leveraging our knowledge of the JAK-STAT pathway to identify and develop topical and oral therapies with the potential to modulate immune pathways driving uncontrolled inflammation and help restore normal immune function.

Currently, Incyte is exploring the potential of JAK inhibition for a number of immune-mediated dermatologic conditions with a high unmet medical need, including atopic dermatitis, vitiligo and hidradenitis suppurativa. To learn more, visit the Dermatology section of Incyte.com.

About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

Forward-Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the Company’s ongoing clinical development program for ruxolitinib cream as well as its dermatology program generally, and whether and when ruxolitinib cream will be approved for use in the U.S. or elsewhere for atopic dermatitis or any other indication, contain predictions, estimates and other forward-looking statements.

These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the Company’s dependence on its relationships with its collaboration partners; the efficacy or safety of the Company’s products and the products of the Company’s collaboration partners; the acceptance of the Company’s products and the products of the Company’s collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

Contact information

Incyte:
Media
Jenifer Antonacci
+1 302 498 7036
jantonacci@incyte.com

Catalina Loveman
+1 302 498 6171
cloveman@incyte.com

Kathleen Cuca
+1 302 498 7886
kcuca@incyte.com

Investors
Christine Chiou
+1 302 274 4773
cchiou@incyte.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

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

Latest releases from Business Wire

CGTN: China Outlines Plan to Address Economic Challenges in Next 5 Years5.3.2021 14:02:00 CETPress release

China has set a gross domestic product (GDP) growth target of over six percent for 2021 and outlined a plan to promote innovation, green development, and common prosperity in the next five years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210305005288/en/ Addressing the country's annual legislative session, Premier Li Keqiang on Friday explained how China is going to tackle the numerous challenges it faces in a new development stage. "China remains in an important period of strategic opportunity for development. Yet, there are changes in both the opportunities and challenges we face," Li said when delivering a government work report at the opening meeting of the fourth session of the 13th National People's Congress (NPC), China's top legislature. 'Extraordinary year' Describing 2020 as "an extraordinary year in the history of the People's Republic of China," the premier underscored China's "major strategic success" in fi

Everbridge Awarded Revolutionary New Public Warning Patent for Technology that Automates the Selection of the Optimal Communications Channels to Reach the Broadest, Hyper-Targeted Populations – as Fast as Possible – During a Crisis5.3.2021 13:30:00 CETPress release

Everbridge, Inc. (NASDAQ: EVBG), the global leader in critical event management (CEM), today announced the company received a revolutionary new patent related to its world-class Public Warning system. The patent pertains to technology focused on hybrid population alerting systems and intelligent sending of messages in public mobile networks. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210305005260/en/ Everbridge Awarded Revolutionary New Public Warning Patent (Photo: Business Wire) Everbridge represents the first population alerting provider to serve the entire populations of 11 countries in Europe, Asia, Oceania, the Middle East, Africa, and the Americas, supporting five European Union (EU) countries in conjunction with the EU mandate requiring member countries to have a population-wide alerting system in place by June 2022. In compliance with GDPR, Everbridge Public Warning neither collects nor stores personally identif

COVID-19’s Economic Pinch Drives More Nordic Enterprises Toward Business Process Automation for Competitive Edge5.3.2021 10:00:00 CETPress release

Large enterprises in the Nordics have been implementing business process automation over the last three years, and more organizations now see the urgency of adopting these technologies to stay competitive as COVID-19 strains the regional economy, according to a new report published today by Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm. The 2020 ISG Provider Lens™Intelligent Automation – Solutions and Services report for the Nordics finds banking, financial services and insurance companies have led the region in adopting business process automation, seeking higher productivity, cost savings and improved customer experience. Manufacturing, retail and other sectors are also embracing the technologies, which include conversational AI, natural-language processing and AI for IT operations (AIOps). “Early adopters of automation in the Nordics are stepping up digital transformation to gain an advantage when they need it most,” said Jan

International Fashion Designer Anna Chybisova Draws Major Investments Worth $9 Million for her Brand Maison d’Angelann5.3.2021 09:52:00 CETPress release

Following a series of successful market takeovers, Anna Chybisova takes another step towards success by securing another major investment for Maison D’angelann. The Gate Business Service, a private family office based out of the United Arab Emirates, has been announced as the latest investor to back Anna’s brand globally. After having invested $7 million late last year, Gate Business Service secures an additional $2 million worth of investment against a majority stake in Maison d’Angelann fashion brand. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210305005133/en/ Anna Chybisova, Fashion Designer & Owner, Maison d’Angelann (Photo: AETOSWire) Anna Chybisova’s designs and business acumen are the foremost reasons behind such heavy investments by the new partner. Reporting sales over $2 million within UAE alone and a sold-out Spring/Summer 2021 collection has strengthened the investor confidence. This growing success and custo

Xlife Sciences AG (XLS): Joint Venture With anfass Life Technologies5.3.2021 08:48:00 CETPress release

Xlife Sciences AG and Solothurn-based anfass Life Technologies AG have entered a joint venture. Hence, the jointly founded Quadira Biosciences AG has access to the 3D CoSeedis(TM) technology platform of abc biopply ag. This unique 3D cell technology enables the replication of human tissue for reliable testing and characterization of antibodies without animal testing. Xlife's technology platform for the development of antibodies will be used even more efficiently. As of today, Xlife Sciences AG has already identified 30 compounds with blockbuster potential with its antibody screening platform. These therapeutic antibodies have already shown to be safe and effective in humans. Xlife can modify these antibodies with utmost accuracy and increase the quality of the active ingredient. These are mainly advanced, highly potent antibodies with higher cytotoxic activity and improved side effect profile for cancer therapy. The target market potential of the pre-selected antibodies is in the range

Moody’s Analytics Wins IFRS 9 Solution Provider of the Year5.3.2021 08:30:00 CETPress release

Moody’s Analytics has won IFRS 9 Solution Provider of the Year in the 2021 Insurance Asset Risk Awards. It is the latest recognition for our capabilities in this space following wins for IFRS 9 – Enterprise Solution of the Year and IFRS 9 – ECL Modelling Solution of the Year at last year’s Risk Technology Awards. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210304006204/en/ Central to our offering for insurers is the ImpairmentStudio™ for IFRS 9 solution, a cloud-based platform that brings together our award-winning economic scenarios, data, models, and enterprise software. Financial institutions use it to automate the credit loss impairment calculations mandated by the new IFRS 9 accounting standard. For insurers, these new financial reporting requirements call for much more granular data than was previously needed. The Moody’s Analytics offering helps them access and use all of the required data while managing and monito

Mitsubishi Heavy Industries Engineering to Test Carbon Capture Technology at Technology Centre Mongstad in Norway5.3.2021 07:43:00 CETPress release

Mitsubishi Heavy Industries Engineering (MHIENG), part of Mitsubishi Heavy Industries (MHI) Group, has entered into an agreement with Technology Centre Mongstad (TCM) to test its proprietary solvent for capturing CO2 at the amine plant located in Mongstad, Norway. The test campaign will start in May. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210304006210/en/ Technology Centre Mongstad located at the west coast of Norway (Photo: Business Wire) The proprietary solvent to be tested is the KS-21TM, an amine-based adsorbent used in the “Advanced KM CDR ProcessTM” newly developed by MHIENG in collaboration with Kansai Electric Power Co., Inc. (KEPCO). Its long-term usage will be demonstrated in Norway, one of the world’s most advanced countries with respect to environmental regulations on CO2 capture, in a quest to achieve commercialization within 2021. Compared to the earlier KS-1TM solvent, which has been adopted at 13 comm