Drugs

FDA Dismisses Study as Support for Makena Approval

CDER says a recently published meta-analysis of progestogen use to reduce pre-term birth (PTB) risk is not persuasive and will not change its course to withdraw Amag Pharmaceuticals’ Makena (hydroxyprogesterone caproate injection) from the market. Late last year, FDA proposed a rare product approval reversal for Makena because a required postmarket study failed to verify clinical benefit in reducing the risk of preterm birth in women who previously had a spontaneous (unexplained) preterm birth. Makena was granted accelerated approval, which required the company to conduct a clinical trial to confirm the drug provided clinical benefit to newborns.

A 3/26 CDER statement confirms that its proposed Makena withdrawal was “based upon a large randomized trial that failed to confirm the benefit of this drug to newborns or reduce the risk of PTB.” It says it also “reviewed results from prior studies of progestins (hydroxyprogesterone caproate (HPC) and other similar drugs) for PTB, including studies relevant to Makena that are included in the EPPPIC meta-analysis. Therefore, the publication of the EPPPIC meta-analysis does not change CDER’s proposal to withdraw the approval of Makena.”

CDER further explains that the meta-analysis “grouped together HPC trials of patients with differences in their risk profiles, including combining women with a prior PTB and those without a prior PTB, and women with and without a short cervix. Because of this grouping, the meta-analysis does not provide relevant information regarding Makena’s effectiveness for its approved use. CDER continues to conclude the available data have not shown Makena is effective for reducing morbidity or mortality in newborns or for the prevention of recurrent PTB in women with a prior spontaneous PTB.”

Amag has requested a hearing on the proposal and the Commissioner’s Office will determine whether to hold a public hearing, the Center 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