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 i.e. sustained responder rate @2yrs. (69.8%)- 88.3% of women who discontinued treatment @52wks. relapsed with heavy menstrual bleeding- with a median time of return to heavy menstrual bleeding of 5.9wks.
• Relugolix combination tablet is under review from US FDA with an anticipated PFUFA date is Jun 01- 2021

 ­ Ref: Pfizer | Image: Bloomberg Quint