Drugs

FDA Panel Shoots Down Makena’s Continued Availability

FDA’s Obstetrics Reproductive and Urologic Drugs Advisory Committee10/19 voted 14 to 1 to recommend the market withdrawal of Covis’ Makena (hydroxyprogesterone caproate injection, 250 mg/mL, once weekly) because data show the accelerated-approval drug is not effective. It was approved in 2011 for reducing the risk of pre-term birth in women with a singleton pregnancy.

During the panel meeting, FDA reiterated its position expressed in a briefing document released in advance of the hearing that argued strongly that the drug is not effective and has known risks. FDA said 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also fail to show that Makena reduces the risk of recurrent preterm birth,” it said in arguing that the drug should be withdrawn from the market.

Covis argued to keep the drug on the market while it conducted a prospective, randomized, double-blind, placebo-controlled trial, but FDA said this would take at least 10 years to conduct. The agency said such a trial is not feasible while Makena is still on the market, and patients are “less likely to enroll in trial for a drug approved to treat a serious condition and risk receiving a placebo when they can simply receive the drug by not enrolling in such a trial.”

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