Drugs

Boehringer’s Jascayd OK’d for Pulmonary Fibrosis

FDA has approved a Boehringer Ingelheim NDA for Jascayd (nerandomilast) tablets for treating idiopathic pulmonary fibrosis (IPF). The oral phosphodiesterase 4B (PDE4B) inhibitor was approved based on results from two randomized, double-blind, placebo-controlled trials showing that Jascayd significantly slowed lung function decline compared with placebo, according to an agency release.

The primary endpoint in both studies was change from baseline in forced vital capacity (FVC), a key measure of disease progression in IPF. Patients receiving Jascayd experienced a smaller FVC decline over the study period, suggesting a measurable impact on fibrosis progression, the agency says.

The most frequently reported adverse events (greater than 5%) in Jascayd-treated patients included diarrhea, upper respiratory tract infection, COVID-19, depression, decreased appetite, weight loss, nausea, fatigue, headache, vomiting, back pain, and dizziness, according to the agency. No new safety signals emerged beyond those observed in prior studies of PDE4B inhibitors, it says.

FDA notes that Jascayd’s approval marks the first advancement in IPF treatments since 2014, when the FDA cleared pirfenidone and nintedanib. IPF remains a rare, fatal interstitial lung disease with no cure, characterized by progressive fibrosis of lung tissue that restricts oxygen exchange and leads to respiratory failure, it adds.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome