Drugs

Don’t Approve Amryt’s Filsuvez NDA: Petition

An 11/7 petition filed by Lassman Law & Policy on behalf of an unnamed client asks FDA not to approve a pending NDA for Amryt Pharma’s Filsuvez (oleogel-S10) to treat cutaneous manifestations of junctional and dystrophic epidermolysis bullosa (EB) without additional clinical data demonstrating it is safe and effective for the indication. The petition specifically asks that FDA:

refrain from approving Filsuvez to treat EB unless and until Amryt provides “substantial evidence” of effectiveness consisting of, at a minimum, at least one successful and well-controlled pivotal clinical trial that uses the detailed procedures and endpoints described in an FDA 2006 wound guidance;
consider the potential consequences for patient health if Filsuvez were to be approved without meeting the guidance standards;
deny any Amryt requests to deviate from the wound guidance; and
refrain from approving Filsuvez to treat EB unless and until appropriate carcinogenicity studies have been completed and support a finding that it is safe for its intended use.

The petition notes that FDA recently approved Krystal Biotech’s Vyjuvek (beremagene geperpavec-svdt) to treat EB. It says approval of Filsuvez based on an inadequate data set could “not only expose patients suffering from EB to an unproven and potentially unsafe and ineffective treatment, but also could impede many eligible DEB (dystrophic EB) patients from using Vyjuvek…. Because of the serious and progressive nature of DEB, even minor delays in effective treatment pose a serious public health concern.”

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