Biologics

Dupixent sBLA for Chronic Spontaneous Urticaria

FDA has accepted for review a Regeneron Pharmaceuticals supplemental BLA for Dupixent (dupilumab) for treating adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) that is not adequately controlled with the current standard of care (H1 antihistamine treatment). The company describes CSU as an inflammatory skin condition driven in part by Type 2 inflammation, which causes sudden hives and swelling on the skin. The agency has set a review action target date of 10/22.

The submission is based on data from two Phase 3 trials (LIBERTY-CUPID Studies A and B) evaluating Dupixent in two different patient populations with uncontrolled CSU. Study A assessed CSU patients who were uncontrolled on standard-of-care antihistamines, and Study B was conducted in CSU patients who were uncontrolled on standard-of-care antihistamines and refractory to omalizumab, according to the company.

Regeneron says Dupixent’s development program has demonstrated clinical benefit and a decrease in Type 2 inflammation in Phase 3 trials, “establishing that IL-4 and IL-13 are key and central drivers of the Type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis and eosinophilic esophagitis (EoE).”

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