U.S. FDA approves Boehringer’s JASCAYD® (nerandomilast tablets) as first new treatment option for adults with IPF in over a decade

Ingelheim, Germany/Ridgefield, Connecticut, U.S.

• Idiopathic pulmonary fibrosis (IPF) is a progressive disease, causing a continuous decline in lung function.¹
• Approval is based on results from two clinical trials, which showed reduction in Forced Vital Capacity decline with JASCAYD versus placebo in adults with idiopathic pulmonary fibrosis (IPF).^2,3
• Nerandomilast is a new treatment option for adult patients with IPF with a well-tolerated safety profile.^2,3

Boehringer Ingelheim’s JASCAYD^® (nerandomilast) tablets has been approved by the U.S. Food and Drug Administration (FDA) as an oral treatment option for idiopathic pulmonary fibrosis (IPF) in adult patients.² JASCAYD is the first and only preferential inhibitor of phosphodiesterase 4B (PDE4B) to be approved in this indication. This represents a novel mechanism of action that exerts both antifibrotic and immunomodulatory effects, thereby slowing the decline in lung function in IPF patients.^2,3 

“This milestone represents a new era in the treatment of IPF, a rare and debilitating chronic condition that worsens lung function. Nerandomilast has proven to slow lung function decline in IPF,” said Toby Maher, M.D., Ph.D., Professor of Clinical Medicine, Keck School of Medicine, USC Los Angeles. “Nerandomilast is a welcome new treatment option with a well-tolerated safety profile for physicians to consider for appropriate patients.”

The FDA approval is based on data from two clinical trials: FIBRONEER™-IPF (NCT05321069) and Trial 2 (NCT04419506). The primary endpoint in FIBRONEER™-IPF was the absolute change from baseline in Forced Vital Capacity (FVC), a measure of lung function,⁴ in mL at week 52.^2,3 Nerandomilast demonstrated a significantly smaller FVC decline compared to placebo.^2,3 Specifically, the adjusted mean decline in patients receiving 18 mg or 9 mg nerandomilast was -106 mL and -122 mL, respectively, versus -170 mL in the placebo group.² Additionally, a treatment effect was shown as early as week two with nerandomilast 18 mg compared to placebo, with changes from baseline in FVC continuing to diverge over time to week 52.^2,3

“The FDA approval of nerandomilast is a pivotal moment for people living with IPF as this marks the first time in over 10 years that the treatment landscape is evolving,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “This new step forward, driven by the compelling results of the FIBRONEER™-IPF trial, underscores our unwavering commitment to change the way we treat IPF by delivering innovative therapies like nerandomilast.” 

The most common (≥5%) adverse reactions reported in patients treated with nerandomilast and more frequently than the placebo group were as follows for nerandomilast 18 mg, 9 mg and placebo, respectively: diarrhea (42%, 31%, 17%), COVID-19 (13%, 16%, 12%), upper respiratory tract infection (13%, 11%, 10%), depression (12%, 11%, 10%), weight decreased (11%, 10%, 8%), decreased appetite (9%, 9%, 5%), nausea (8%, 9%, 7%), fatigue (7%, 8%, 6%), headache (7%, 6%, 5%), vomiting (6%, 5%, 5%), back pain (6%, 5%, 4%) and dizziness (5%, 6%, 5%).²

Discontinuation due to adverse reactions occurred more frequently in patients treated with nerandomilast (with or without background antifibrotic treatment) 18 mg (15%) and 9 mg (12%) compared to placebo (11%).² The most frequent adverse reaction leading to discontinuation of nerandomilast 18 mg and 9 mg was diarrhea (6% and 2%, respectively).²

There is no ‘Warnings and Precautions’ section in the FDA approved product label.²

“The FDA approval of nerandomilast is exciting news for people living with idiopathic pulmonary fibrosis and their caregivers,” said Scott Staszak, President and CEO of the Pulmonary Fibrosis Foundation. “There has been a long-standing need for new treatment options for IPF within our community and nerandomilast provides an important addition to the care landscape.”

About IPF

IPF is one of the more common progressive fibrosing interstitial lung diseases.¹ It is deadlier than many forms of cancer, with a lower five-year survival rate compared to prostate cancer, female breast cancer and colon cancer.^5,6 IPF substantially impacts quality of life and half of patients succumb to the disease within five years of diagnosis.^7,8 In IPF, the root cause of pulmonary fibrosis is not known.¹ Symptoms and signs of IPF include a dry and persistent cough, shortness of breath, fatigue and finger clubbing (widening and rounding of the topics of the fingers).⁹ IPF may affect up to 3.6 million people worldwide, and an estimated 200,000 people in the U.S.^10-13 The disease primarily affects people over the age of 50 and affects more men than women.¹⁴

About nerandomilast

Nerandomilast is an oral, preferential inhibitor of PDE4B approved in the U.S. for the treatment of IPF in adult patients.² Nerandomilast was approved by the FDA after securing Priority Review and Breakthrough Therapy Designation.

Regulatory submissions for nerandomilast in IPF are also under review in China, Japan, and the EU, with filings in other geographies to follow.

About Boehringer Ingelheim

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

MPR-CRP-100533 / MPR-US-103605

References

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