It's been more than 10 years since the FDA signed off on Merck KGaA's fertility drug Luveris. But now, after the company failed to conduct a postmarketing trial, the FDA has yanked the drug's approval at the German pharma's request.
Because Merck KGaA did not complete the postmarketing study required after its approval, "the clinical benefit of Luveris has not been confirmed, and it has not been established to be safe and effective" in treating women with hormone deficiencies, the FDA said in a recent notice.
The company's decision to withdraw its application for Luveris "was not due to any safety or efficacy concern," Merck KGaA told FiercePharmaMarketing in an email. The company couldn't complete postmarketing trials requested by the agency because it was too difficult to recruit women with hypogonadotropic hypogonadism, which comprises a small patient population.
The company won accelerated approval for the drug in 2004, but only after experts at an FDA advisory committee meeting questioned the drug's efficacy. None of the placebo-controlled studies gave enough evidence to support Luveris' ability to treat infertility, and results from a European study were "significantly different" from those in a U.S. study, the panel said. They did not question Luveris' safety.
Because of those questions, the FDA green light required Merck KGaA to run a postmarketing trial to confirm its benefits. But by 2012, the company still hadn't conducted that trial and asked the FDA to withdraw approval for Luveris. The company also wrote healthcare professionals to say that the drug would be discontinued in the U.S., and it stopped shipping the drug to wholesalers and pharmacies. It didn't mention the postmarketing study.
A few years later, in July 2015, the company wrote regulators again, asking them to take back approval for the drug because the postmarketing studies weren't complete. Merck KGaA also waived its option to have a hearing about the issue.
The FDA acknowledged the company's request last fall, and now, it apparently has granted Merck KGaA's wish. The agency's latest move makes interstate marketing of the drug "illegal and subject to regulatory action," it said in its notice.
Merck KGaA hasn't completely pulled the plug on Luveris, however. The drug is available and marketed in Europe, the company said.
And the German drugmaker "remains committed to serving patients with infertility through its portfolio of products and patients support programs," the company said. Another one of the company's fertility drugs, Gonal-f, posted €167 million in Q3 sales, which contributed to Street-beating earnings for the quarter.
- get the FDA notice (PDF)