Nearly two years after an FDA advisory panel determined Covis Pharma’s controversial premature-birth med Makena should be taken off the market after failing a key post-approval study, the agency is giving the company a chance to plead its case.
The FDA granted Covis a hearing that'll help determine the fate of its key med, known as Makena, the company said Thursday. The treatment first scored an accelerated approval in 2011 under KV Pharmaceuticals but later landed at Covis when the company acquired AMAG Pharmaceuticals last year.
Makena ran into a major hurdle in late 2019 when an advisory panel voted 9 to 7 to recommend its marketing withdrawal after the drug didn’t show benefit over placebo in a key confirmatory trial. Following the committee’s recommendation, the FDA's Center for Drug Evaluation and Research (CDER) officially proposed withdrawing the marketing approval last October.
Instead of rolling over to the FDA’s requests, however, AMAG and Covis pushed back on the committee’s ruling. The pair requested the agency hold a hearing to review its case for taking Makena off the market, Stat News reported.
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The drugmaker has not only “satisfied” the procedural steps for the hearing, but its “response provides specific challenges to the factual and scientific bases underlying CDER’s proposal and includes or describes data and information in support of those challenges,” according to the FDA.
“I find that, taken as a whole, Covis’s response raises genuine and substantial issues of fact appropriate for a hearing,” FDA Chief Scientist Denise Hinton wrote in a letter to Covis' attorneys.
The hearing, which hasn't been scheduled, will mark the latest chapter in what has been a controversial chronicle for Makena, which is used to prevent preterm birth in pregnant women with a history of spontaneous preterm birth.
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Shortly after KV Pharmaceuticals scored its FDA nod, the company drew fierce backlash for pricing the treatment at $1,500 per injection. Before the FDA’s approval, the drug went for under $20 through compounding pharmacists, which also make the drug’s progesterone ingredient for competitors.
The fate of the generic versions also rides on the agency’s eventual Makena decision because, by law, the FDA would have to pull those alongside Makena, Kaiser Health News reported last year.
That’s partly why some FDA advisory members voted to keep Makena on the market. They argued that pulling the pregnancy med would cause more harm than good given the synthetic hormone 17-hydroxyprogesterone caproate, or 17P, has previously shown promise, according to KHN.