Drugs

FDA Seeks Covis Info for Makena Hearing

FDA has released a CDER letter sent to the presiding officer for an upcoming hearing on whether the approval for Covis’ Makena should be withdrawn, asking that Covis be directed to provide additional information. The letter asks for additional information on four tables included in the Covis submission and on a new provider survey so CDER can respond to the company submission.

Last week, an FDA briefing document released in advance of the 10/17-19 advisory committee meeting to discuss whether the accelerated approval of Covis’ Makena (hydroxyprogesterone caproate injection, 250 mg/mL, once weekly) should be withdrawn argues strongly that the drug is not effective and has known risks. It was approved in 2011 for reducing the risk of pre-term birth in women with a singleton pregnancy.

In the briefing document, FDA says Makena has not been shown to improve neonatal outcomes from premature birth, and that its confirmatory trial “failed to show that Makena has any benefit to newborns. Data from this trial, taken together with other evidence, also fail to show that Makena reduces the risk of recurrent preterm birth,” it says in arguing that the drug should be withdrawn from the market.

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