Drugs

FDA Memo Recommends Califf Order Makena’s Withdrawal

Covis Pharma’s Makena (hydroxyprogesterone caproate injection) for reducing the risk of preterm birth in certain women should be withdrawn from the market because the drug does not have a favorable benefit-risk profile, says an FDA recommendation memo to FDA commissioner Robert Califf and chief scientist Namandjé Bumpus. The two officials will consider the recommendation in making the final decision for the agency on CDER’s proposal to withdraw Makena’s approval.

The memo was written by CBER deputy director Celia Witten, who served as FDA’s presiding officer during a CDER 10/19/2022 withdrawal hearing by its Obstetrics Reproductive and Urologic Drugs Advisory Committee. The panel voted 14 to 1 to also recommend Makena’s withdrawal (see story).

Witten’s memo said that based on the “analyses presented at the hearing, I do not believe effectiveness has been demonstrated in any subgroup and think that for this reason the benefit-risk considerations do not favor keeping Makena on the market to preserve access. I also share the view that maintaining an ineffective treatment on the market may impede development of other products for Makena’s labeled indication, which will not serve the cause of furthering health equity.”

Additionally, Witten said there are known risks, and a potential for other risks, including intergenerational safety risks. She also hinted that a new study will be needed to allow the drug back on 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