Myovant and Pfizer’s endometriosis expansion bid for Myfembree has hit a pothole late in the FDA’s review process.
In a letter to the companies, the United States regulator has identified deficiencies that “preclude discussion of labeling and/or post-marketing requirements and commitments at this time.” The partners said there was no further explanation from the FDA and that the application remains under review.
The companies will work with regulators to determine the next steps in the application, they said.
In response, Myovant’s shares were down 16% by mid-morning on Tuesday.
The FDA signed off on the new drug submission in September of last year and assigned a decision date of May 6. Last May, the FDA approved the drug to treat heavy menstrual bleeding linked to uterine fibroids in premenopausal women.