Uterine Fibroids

ObsEva files uterine fibroid drug in US, chasing AbbVie, Myovant

Swiss biopharma company ObsEva has filed its oral GnRH antagonist linzagolix for the treatment of uterine fibroids in the US, hoping to expand the number of women eligible for this type of therapy. If approved, linzagolix will be the only drug in the class with a dosing regimen intended for women with uterine fibroids who …

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ViewPoints Interview: Myovant’s Dave Marek Shares Insights on the US FDA’s Approval of Myfembree in Uterine Fibroids

In an interview with PharmaShots, Dave Marek. CEO of Myovant shares insights on the US FDA’s approval of Myfembree (relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5mg) in Uterine Fibroids. Shots: The US FDA has approved Myovant & Pfizer’s Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) as the first once-daily …

ViewPoints Interview: Myovant’s Dave Marek Shares Insights on the US FDA’s Approval of Myfembree in Uterine Fibroids Read More »

Myovant’s Ryeqo (relugolix, estradiol, and norethindrone acetate) Receives EC’s Approval for the Treatment of Women with Uterine Fibroids

Shots: The approval is based on safety & efficacy data from the P-III LIBERTY program that consists of 2 studies i.e LIBERTY 1 & 2 evaluating Ryeqo in adult women with UF with no limitation for a duration of use. The EC’s decision is valid in all 27 member states of the EU, Iceland, Norway …

Myovant’s Ryeqo (relugolix, estradiol, and norethindrone acetate) Receives EC’s Approval for the Treatment of Women with Uterine Fibroids Read More »

FDA clears Myovant’s relugolix for uterine fibroids, setting up AbbVie clash

Myovant has chalked up a second approval for its flagship drug relugolix from the FDA, becoming the first once-daily oral drug in the US to treat heavy menstrual bleeding associated with uterine fibroids.  The drug will be sold as Myfembree (relugolix) for the uterine fibroids indication, and is already available to treat prostate cancer under …

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Pfizer and Myovant’s Myfembree Receive the US FDA’s Approval for Heavy Menstrual Bleeding Associated with Uterine Fibroids

Shots: The approval is based on efficacy and safety data from the P-III LIBERTY 1 & 2 studies assessing Myfembree (relugolix 40 mg, estradiol 1 mg & norethindrone acetate 0.5 mg) vs PBO for heavy menstrual bleeding associated with uterine fibroids in premenopausal women with a treatment duration for up to 2yrs. The P-III studies …

Pfizer and Myovant’s Myfembree Receive the US FDA’s Approval for Heavy Menstrual Bleeding Associated with Uterine Fibroids Read More »

Pfizer and Myovant Report Results of Relugolix Combination Therapy in P-III LIBERTY Withdrawal Study in Women with Uterine Fibroids

Shots: The P-III LIBERTY withdrawal study involves assessing Relugolix combination therapy [relugolix (40 mg) + estradiol (1.0mg) & norethindrone acetate (0.5mg)] vs PBO in women with uterine fibroids for 24wks. The study met its 1EPs i.e. achieving the sustained responder rate @76wks. (menstrual blood loss < 80 mL) (78.4% vs 15.1%). The study met 2EPs …

Pfizer and Myovant Report Results of Relugolix Combination Therapy in P-III LIBERTY Withdrawal Study in Women with Uterine Fibroids Read More »