FDA Panel Gives Ulipristal Acetate Unanimous Positive Vote

June 18, 2010 — The US Food and Drug Administration (FDA)'s Reproductive Health Drugs Advisory Committee voted unanimously in favor of approving the new drug application (NDA) for ulipristal acetate tablets, 30 mg (ellaOne; Laboratoire HRA Pharma), for use as an emergency contraceptive.

The committee discussed NDA 22-474, for ulipristal acetate, a first-in-class, orally active selective progesterone modulator. This agent can be taken 120 hours after unprotected sexual intercourse, which is longer than the 72-hour time frame associated with currently available emergency contraceptives in the United States.

The 11-member committee voted unanimously that sufficient information was available about the efficacy of ulipristal. They also agreed that the safety profile appeared to be acceptable for the proposed indication.

For Sandra Carson, MD, chairman of the advisory panel and an obstetrician/gynecologist with Brown University, in Providence, Rhode Island, the sponsoring company, HRA Pharma, presented adequate data. "Of course, there can always be more," she said. "But the data is very reassuring."

Approved in Europe

The committee's vote was based on a review of data from the ulipristal acetate preclinical and clinical development program including more than 4000 women from the United States and Europe.

Ulipristal acetate was approved in May 2009 by the European Commission for marketing as an emergency contraceptive within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure. The product was launched in October 2009 and is marketed today in 22 countries in Europe.

The committee also supported the idea that no special product labeling will be required for use in obese women (ie, those with a body mass index of >30 kg/m²) or in adolescents.

The committee also voted unanimously "no" to the question of whether there is a need for measures beyond product labeling/healthcare provider education to address potential off-label use of ulipristal.

The panel agreed that there is no scientific evidence that at the dose recommended, ulipristal causes abortion. "It pretty much only works by preventing ovulation," said meeting attendee David F. Archer, MD, from the Eastern Virginia Medical School, in Norfolk. "I just don't think there's any element here that would allow me to say that this has abortifacient activity," he added.

The panelists maintain that it should be made clear that pregnancy testing is not a requirement for use of ulipristal, although it is likely that many clinicians will order this as part of the use of the drug.

Although in this case the voting was unanimous, the FDA is not bound by the recommendations of its advisory committees and will conduct a review of the application for final approval in the coming months.

HRA Pharma has entered into a licensing agreement with Watson Pharmaceuticals to commercialize ulipristal in the United States.

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Cite this: FDA Panel Gives Ulipristal Acetate Unanimous Positive Vote for Emergency Contraception Indication - Medscape - Jun 18, 2010.

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