After a three-month snag at the FDA this spring, Pfizer and Myovant’s bid to to expand Myfembree's use is closing in, and during its recent fiscal first-quarter earnings release, Myovant teased a speedy launch.
Earlier this year, the FDA sent letters to Pfizer and Myovant flagging problems that meant conversations about labeling or postmarketing requirements couldn't proceed for Myfembree in endometriosis pain. Since then, Myovant said in its quarterly earnings press release, the FDA provided it with labeling comments for the gonadotropin-releasing hormone (GnRH) antagonist.
The FDA's action date is Aug. 6. An approval would trigger a $100 million milestone payout for Pfizer, which laid out $650 million upfront in Dec. 2020 to get a piece of the Myfembree action.
Further, the partners said they’ll waste no time on launch, with plans to roll out Myfembree in endometriosis pain management next month, should a green light come.
The disease represents a “significant opportunity” for the partners, Lauren Merendino, Myovant’s chief commercial officer, said on a recent investor call. Some 8 million women live with the disease in the U.S., among whom about 6 million experience frequently debilitating symptoms, the CCO explained.
Myfembree was first approved last May for uterine fibroids. Its established foothold in the uterine fibroids arena would allow Myovant and Pfizer to “accelerate quickly into this new market,” Merendino added.
“We're really excited about the potential if we do get approved in endometriosis,” Myovant CEO Dave Marek said during a question & answer portion of the company’s earnings call. “We think a lot of the same characteristics that the customer base is looking for in uterine fibroids parallels to what they're looking for in endometriosis.”
CCO Merendino further outlined three factors that could boost Myfembree’s potential breakthrough into endometriosis.
“From a payer perspective, we already have payer coverage established for uterine fibroids, and this would be considered a line extension,” she said. “So, we believe we can move quickly to secure payer coverage.”
What’s more, Myfembree already boasts a “base of prescribers” who are well-acquainted with the med, Merendino added.
Finally, there’s a high overlap between uterine fibroids and endometreosis prescribers, which means Myovant and Pfizer should be able to seize their endometriosis opportunity “quickly,” she said.
Myfembree was originally up for a U.S. decision in endometriosis on May 6. In mid-April, the FDA sent letters to Pfizer and Myovant flagging deficiencies that precluded “discussion of labeling and/or postmarketing requirements and commitments.” At the time, the partners said there was no further explanation from the FDA and that Myfembree’s application was still under review.
Aside from the regulatory glitch, Myfembree has been doing relatively well for Myovant commercially. The company reported total revenue of $116.5 million for 2022's first fiscal quarter. Myfembree is the top GnRH antagonist therapy for uterine fibroids, with a 51% share of all prescriptions as of June 2022, Myovant added in its earnings press release.
While the drug pitched in just $4 million during Myovant's first fiscal quarter, the med is the market leader in new-to-brand prescriptions for GnRH agonists in the U.S., Myovant pointed out.