Regulatory Focus™ > News Articles > FDA Withdraws NDA for Fertility Drug After EMD Serono Fails to Run Postmarket Trial

FDA Withdraws NDA for Fertility Drug After EMD Serono Fails to Run Postmarket Trial

Posted 11 April 2016 | By Zachary Brennan 

FDA Withdraws NDA for Fertility Drug After EMD Serono Fails to Run Postmarket Trial

More than 10 years since the US Food and Drug Administration (FDA) offered accelerated approval to EMD Serono’s fertility drug Luveris (lutropin alpha for injection), the agency on Monday announced it’s withdrawing the drug’s approval as the company failed to run a postmarketing study required as a condition of approval.

First approved on 8 October 2004, Luveris was indicated for concomitant administration with one of EMD Serono’s other fertility treatments, Gonal-F (follitropin alfa for injection), for helping infertile hypogonadotropic hypogonadal women with profound luteinizing hormone deficiency.

Prior to that approval, experts at an FDA advisory committee meeting raised questions about the efficacy of Luveris. FDA staff noted: “None of the placebo-controlled studies provides sufficient evidence to support the efficacy of Luveris,” though the agency had no issue with the drug’s safety profile. The agency also said that the results of a European study were “significantly different” from that of a US-based one on the drug.

More than eight years later, in a letter dated 30 April 2012, EMD Serono requested that FDA withdraw approval of the Luveris new drug application (NDA) (a request which the company made again last July) and said that, “as had been previously discussed with the Agency, it was not feasible to complete a trial that the company had agreed to at the time of approval.”

EMD Serono then sent a letter to health care professionals later in 2012 noting that the drug would be discontinued in the US, and then ceased shipping the drug to wholesalers and pharmacies in July 2012, though the company made no mention of the postmarketing study.

EMD Serono Spokeswoman Erin-Marie Beals told Focus: "Despite concerted efforts, the company was unable to complete the post-marketing trials requested by the FDA due to the difficulty in recruiting hypogonadotropic hypogonadal women, a small patient population. Further, the medical need of female patients with this condition is addressed with other therapeutic options in the US. The company’s decision to withdraw the NDA was not due to any safety or efficacy concern." 

“Because that study was required to verify and describe the clinical benefit of the drug product, the clinical benefit of Luveris has not been confirmed, and it has not been established to be safe and effective,” FDA said in a notice on Monday, which was a reiteration of concerns from other correspondence to EMD Serono in 2014.

Meanwhile, Luveris is still available in the EU and was approved by the European Medicines Agency in 2000. EMD Serono said the status is unchanged since FDA's decision.

Article updated 4/12/16 with comment from EMD Serono.

EMD Serono; Withdrawal of Approval of a New Drug Application for LUVERIS

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