Drugs

Brinsupri Approved for Non-Cystic Fibrosis Bronchiectasis

FDA has approved an Insmed NDA for Brinsupri (brensocatib) tablets as the first treatment for non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 and older. “There have been no approved therapies for NCFB,” an FDA release says. “Before today’s action, patients relied on antibiotics and symptom management, such as physiotherapy, supplemental oxygen, and mucolytics, which are medications to loosen mucus.”

NCFB is described by the agency as a progressive inflammatory disease that damages the lungs, causing persistent cough, shortness of breath, and recurrent infections. It can develop after prior lung infections, chronic obstructive pulmonary disease, autoimmune disorders, or immune system deficiencies. Between 230,000 and 430,000 Americans are affected by the condition.

FDA says Brinsupri blocks the enzyme dipeptidyl peptidase, which plays a role in the inflammation that drives NCFB. Its approval was based on two multinational, randomized, placebo-controlled trials involving 1,915 adults and 41 adolescents. In one study, both Brinsupri doses significantly reduced the annualized rate of flare-ups — defined as worsening of at least three major symptoms within 48 hours requiring antibiotics — and prolonged the time to the first flare-up compared with placebo. The second trial confirmed the extended time to first flare-up for both doses.

Brinsupri’s labeling carries warnings for skin reactions and gum and tooth problems, advising patients to seek dermatologic and dental care while on treatment, FDA says. Common side effects include upper respiratory tract infections, headache, rash, dry skin, thickened skin, and high blood pressure. Less common effects include elevated liver enzymes, hair loss, and certain skin cancers, 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