Drugs

FDA Rejects Viatris/Mapi Multiple Sclerosis Drug

FDA has issued Viatris/Mapi Pharma a complete response letter on their NDA for GA Depot 40 mg, a long-acting glatiramer acetate being investigated as a once-monthly injection to treat relapsing forms of multiple sclerosis. The companies say they are reviewing the letter’s content and will be determining the appropriate next steps.

The NDA is supported by results from a multinational Phase 3 trial evaluating the efficacy, safety, and tolerability of GA Depot compared with placebo in patients with relapsing multiple sclerosis, the companies say. “The study concluded that the product offers a preferable schedule and with expected fewer injection site reactions than other GA products,” they say. “The study met its primary endpoint showing that GA Depot 40 mg statistically significantly reduced the annualized relapse rate by 30.1% compared to placebo.”

GA Depot is described as a long-acting version of the FDA-approved glatiramer acetate commercially available as Teva’s daily dosed Copaxone. It also is in a Phase 2 test to treat primary progressive multiple sclerosis.

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