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The FDA has approved nerandomilast tablets for the treatment of idiopathic pulmonary fibrosis (IPF) in adults, according to an FDA press release.
Nerandomilast, marketed as Jascayd by its manufacturer Boehringer Ingelheim, is the first therapy approved in more than 10 years for IPF. The drug is a preferential inhibitor of phosphodiesterase 4B and is the first of its kind to be approved for IPF, according to a company press release.
The recommended dose is 18 mg twice daily, approximately 12 hours apart, according to the FDA.
The approval was supported by data from a pair of randomized, controlled trials. In the study, FIBRONEER-IPF, adult IPF patients aged 40 years and older who were randomized to nerandomilast had significantly smaller declines in forced vital capacity compared to placebo patients after 52 weeks.
The difference was evident at doses of 18 mg or 9 mg, with adjusted mean declines of -114.7 mL and -138.6 mL compared to -183.5 mL in placebo patients.
The adverse events that were reported in at least 5% of participants were more common in the 18-mg and 9-mg nerandomilast groups vs placebo. The adverse events were diarrhea, COVID-19, upper respiratory tract infections, depression, weight loss, appetite loss, nausea, fatigue, headache, vomiting, back pain, and dizziness. Of these, diarrhea was most frequently associated with treatment discontinuation. An earlier study showed safety, efficacy, and improved lung function with nerandomilast vs placebo after 12 weeks of treatment.
Regulatory submissions are also under review in China, Japan, and the European Union, according to a company press release. Full prescribing information is available here.
The studies were supported by Boehringer Ingelheim.
