Drugs

Amryt Seeking Dispute Resolution on Filsuvez NDA

Amryt says it will file an FDA formal dispute resolution request over a complete response letter it received in February for its NDA for Filsuvez (oleogel-S10), indicated for treating cutaneous manifestations of dystrophic and junctional epidermolysis bullosa (EB). The rare genetic skin disease, Amryt says, is characterized by extremely fragile skin that blisters and tears from minor friction or trauma and for which there are no approved treatment options in the U.S.

The decision to file for dispute resolution follows a recent Type A meeting with FDA to discuss the complete response letter, which the company earlier said was seeking “additional confirmatory evidence of effectiveness for Oleogel-S10 in EB.”

Amryt says it continues to “believe that the strong body of data from the EASE trial, which was the largest ever Phase 3 trial conducted in EB, supports FDA approval of this vital therapy for EB patients with a high unmet medical need.” Earlier this week, Filsuvez was approved for treating EB in the European Union, the company says.

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