Myovant Sciences Ltd (MYOV)

[DewDiligence]

MYOV/PFE—Myfembree sNDA in endometriosis hits undisclosed snag:

https://www.globenewswire.com/news-release/2022/04/12/2420541/0/en/Myovant-Sciences-and-Pfizer-Provide-Update-on-Supplemental-New-Drug-Application-for-MYFEMBREE-for-the-Management-of-Moderate-to-Severe-Pain-Associated-with-Endometriosis.html

In accordance with the ongoing review of the application, on April 6, 2022, the U.S. 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 and Pfizer will continue to work with the FDA to determine next steps with the application.

The PDUFA date is 5/6/22.