Myovant - Pfizer's Uterine Fibroids Treatment Wins FDA Approval - Pfizer (NYSE:PFE)

The FDA has approved Myovant Sciences Ltd MYOV and Pfizer Inc’s PFE relugolix combined with estradiol and norethindrone acetate for heavy menstrual bleeding linked to uterine fibroids in premenopausal women.
The once-daily treatment will be marketed as Myfembree, with a treatment duration of up to two years.
Wednesday’s approval marks the second FDA nod for Myovant in less than a year after relugolix scored a go-ahead in prostate cancer in December.
The company is also testing its flagship drug in women with endometriosis, another painful disorder involving the uterus’ tissue, and pregnancy prevention medication.
Pfizer will help Myovant sell Myfembree for uterine fibroid patients in the U.S. as early as June.
The FDA based its Myfembree approval on two replicate phase 3 trials, Liberty 1 and Liberty 2, that showed the med significantly beat placebo in preventing blood loss among women with uterine fibroids.
Specifically, 72.1% and 71.2% of women in the relugolix arm responded to the treatment compared with 16.8% and 14.7% of women in the placebo groups after 24 weeks, respectively.
In its approval, the FDA warned that the drug shouldn’t be used for longer than 24 months due to the risk of continued bone loss that may not be reversible.
Price Action: PFE shares are up 0.18% at $38.99, while MYOV shares are down 1.39% at $23.35 during the premarket session on the last check Thursday.
Related content: Benzinga's Full FDA Calendar