BRIEF—FDA delay for Myfembree sNDA

Switzerland-based Myovant Sciences and US pharma giant Pfizer have announced an update on the Supplemental New Drug Application (sNDA) for Myfembree (relugolix 40mg, estradiol 1mg and norethindrone acetate 0.5mg) for the management of moderate to severe pain associated with endometriosis.

In accordance with the ongoing review of the application, on April 6, 2022, the US Food and Drug Administration (FDA) provided notice to the companies that the agency identified deficiencies that preclude discussion of labeling and/or post-marketing requirements and commitments at this time.

The FDA did not provide additional detail. The FDA noted that the letter does not reflect a final decision on the pending sNDA and that the application is still under review.

Myovant, whose shares closed down 25% at $10.39 yesterday, and Pfizer will continue to work with the FDA to determine next steps with the application.

In 2020, Pfizer struck a deal with Myovant potentially worth up to $4.2 billion to develop and commercialize relugolix in oncology and women's health in the USA and Canada.