Shots:

• The P-III LIBERTY 1 & 2 studies involve assessing of relugolix (40mg) + estradiol (1.0mg) & norethindrone acetate (0.5mg) vs PBO in women with uterine fibroids
• The results showed response rates in menstrual blood loss (73.4% & 71.2%) vs (18.9% & 14.7%) @24wks; 84.3% reduction in menstrual blood loss from baseline; maintained bone mineral density; reduction of pain; improvement in anemia and was well tolerated respectively
• Data from LIBERTY 1& 2 study- in addition to the 28-week long-term extension study- were included in the NDA) for relugolix combination tablet with anticipated PDUFA date as Jun 01- 2021

 ­ Ref: Pfizer | Image: Myovant