The U.S. Food and Drug Administration (FDA) has approved nerandomilast (brand name: Jascayd) tablets for the treatment of progressive pulmonary fibrosis (PPF) in adults. This follows the FDA’s October approval of the drug to treat IPF.
According to a press release from developer Boehringer Ingelheim, this milestone represents a new therapeutic option in the United States for PPF — a debilitating lung condition. It makes nerandomilast the first and only preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory and antifibrotic effects approved in this indication.
“People living with progressive pulmonary fibrosis often carry a heavy burden that others don’t always see,” said Scott Staszak, president and CEO of the Pulmonary Fibrosis Foundation. “A progressive disease condition process like PPF can worsen lung function quickly, and patients have been eagerly awaiting additional treatment options. The FDA approval of nerandomilast for PPF is a welcomed milestone for the community.”
The FDA approval is based on results from the pivotal phase 3 FIBRONEER-ILD clinical trial, which showed that nerandomilast effectively slowed lung function decline in PPF with similar permanent discontinuation rates to placebo.
The primary endpoint in the study was the absolute change from baseline in forced vital capacity (FVC) in mL at week 52. Nerandomilast demonstrated a significantly smaller reduction in FVC decline from baseline compared to placebo. Specifically, the adjusted mean decline in absolute change from baseline in FVC in patients receiving nerandomilast 18 mg or 9 mg was -86 mL and -69 mL, respectively, versus -152 mL in the placebo group.
Additionally, in the FIBRONEER-ILD trial, there was an overall survival trend in favor of nerandomilast. The hazard ratios for all-cause mortality until the end of the trial (up to 114 weeks) of both doses of nerandomilast were 0.51 (95% CI: 0.34, 0.78). Nerandomilast was also deemed safe and well-tolerated, with diarrhea as the most common adverse reaction.
“Progressive pulmonary fibrosis is a life-threatening condition with a high unmet medical need,” said Shashank Deshpande, chairman of the board of managing directors and head of human pharma at Boehringer Ingelheim. “The U.S. approval of Jascayd is an important step forward to help slow lung function decline for people living with PPF, providing a new, well-tolerated treatment option.”
Nerandomilast is also approved in China for the treatment of adult patients with IPF and PPF. Regulatory submissions for the drug are under review in other countries, including the European Union, the U.K. and Japan.
