Drugs

CDER Denies NDA ‘Complete Response’ Appeal

CDER’s Office of New Drugs (OND) has denied an Acer Therapeutics appeal of a 6/2019 complete response letter on an NDA for Edsivo (celiprolol) for treating vascular Ehlers-Danlos syndrome (vEDS). The letter said it was necessary to conduct an adequate and well-controlled trial to “determine whether celiprolol reduces the risk of clinical events in patients with vEDS,” according to the company.

In the appeal denial letter, OND described “possible paths forward for Acer to explore that could provide the substantial evidence of effectiveness needed to support a potential resubmission of the Edsivo NDA,” the company says. Acer is evaluating possible next steps to resubmit the NDA, it adds.

vEDS is a collagen production disorder. Collagen is the main protein in connective tissue such as skin, bones, blood vessels, and many other organs and tissues. Eliprolol is a chemical entity originally developed to treat hypertension, and the company says it is thought to provide clinical benefit for people with vEDS by promoting normal collagen synthesis in the blood vessels, and by shifting the pressure load away from the vessels most prone to dissection and rupture. Although it can also be used to treat mild to moderate hypertension, celiprolol does not lower blood pressure in people with normal blood pressure, Acer 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