The FDA has approved Jascayd (nerandomilast) tablets to treat idiopathic pulmonary fibrosis, a rare, progressive lung disease that can cause scarring and breathing difficulties.
The approval marks the first new therapy for IPF approved in more than a decade. The drug’s efficacy was evaluated in two randomized, double-blind, placebo-controlled trials, wherein patients taking Jascayd experienced a significantly smaller decline in forced vital capacity compared with those receiving placebo, according to an Oct. 7 FDA bulletin.
The recommended dosage is 18 mg twice daily, roughly 12 hours apart. Dosage may be reduced to 9 mg twice daily for patients experiencing intolerability, excluding those on pirfenidone.
Common side effects observed in at least 5% of trial participants included diarrhea, COVID-19, upper respiratory tract infection, depression, weight loss, decreased appetite, nausea, fatigue, headache, vomiting, back pain and dizziness.
