Drugs

FDA OKs Dupixent For Allergic Fungal Rhinosinusitis

FDA has approved a Sanofi and Regeneron Pharmaceuticals BLA supplement for Dupixent (dupilumab) and its use for treating adults and children ages 6 and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery, marking the first therapy specifically for the condition. Allergic fungal rhinosinusitis is an uncommon, severe form of chronic sinus inflammation triggered by an allergic reaction to fungi in the sinuses. The condition is characterized by thick, sticky mucus and often occurs in patients who also have nasal polyps, FDA says, and if left untreated, AFRS can lead to progressive sinus expansion, bone erosion — reported in up to 90% of patients — and spread to nearby structures such as the eyes or brain. Complications may include facial deformities, visual impairment and nerve damage.

The approval was supported by data from a 52-week clinical study evaluating dupilumab in adults and pediatric patients aged 6 years and older with AFRS, FDA says. Patients treated with dupilumab demonstrated significant improvement in sinus opacification compared with placebo, as measured by CT imaging using the Lund-Mackay scoring system. Secondary endpoints — including reductions in nasal polyp size, nasal congestion and impaired sense of smell — also showed statistically significant improvements, according to the agency.

Importantly, FDA says patients receiving dupilumab required fewer systemic corticosteroids and underwent fewer sinus surgeries over the 52-week study period compared with placebo-treated patients. The drug also reduced sinus bone erosion, a complication considered unique and particularly serious in AFRS.

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