Astellas’ menopause drug hit by FDA delay after spending $97M on a priority review voucher

In August, Astellas announced that an application for its menopausal symptom drug fezolinetant had been accepted, and it used a priority review voucher — to which it ascribed a $97 million value — to speed up the process by four months.

The original decision deadline was Feb. 22, but today the Japanese pharma announced that the FDA is extending the original PDUFA date by three months to May 22.

Ahsan Arozullah

The delay is expected to have a “minor” impact on Astellas’ fiscal year, which ends March 31, according to the company.

“We remain confident in the clinical profile of fezolinetant and the potential benefits it could bring to women experiencing moderate to severe VMS due to menopause, and we will continue to work with the FDA on its review of the NDA for fezolinetant,” Ahsan Arozullah, SVP and head of development in therapeutic areas at Astellas, said in the short statement.

Fezolinetant is an oral, non hormonal drug that has been touted as a new treatment of moderate to severe vasomotor symptoms associated with menopause, including hot flashes and night sweats.

Astellas acquired the drug through an $860 million buyout of Belgian biotech Ogeda in 2017, and reported positive late-stage and safety data.

The FDA is reviewing three Phase III clinical trials of the drug, which was tested in more than 2,800 women across the US, Canada and Europe in the BRIGHT SKY studies and reported positive efficacy and safety data. In the studies, the drug beat placebo in reducing the frequency and severity of hot flashes in menopausal women at one- and three-month check ins.

But the drug flopped in a 302-patient late-stage study in Asia earlier in 2022. The drug was unable to significantly beat the placebo arm.

The Institute for Clinical and Economic Review (ICER) recommended that fezolinetant be priced between $2,000 and $2,500 per year for women who can’t or who choose not to take menopausal hormone therapy.

In the NDA, Astellas proposed a 45 mg daily dose.

In commercials that debuted on Oct. 24 last year, the company also launched TV ad spots as part of its “What’s VMS” campaign, where women on the street are asked what VMS is in order to spread awareness and increase education.

Recently, the FDA also handed down a delay to argenx — after initially offering priority review — for the BLA review of subcutaneous efgartigimod for treating adults with the autoimmune disease generalized myasthenia gravis (gMG). A spokesperson for the company told Endpoints News that the company is “frustrated that we are not getting an expedited review because we are eager to provide a SC option to patients.”

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