Phase III study of elagolix shows significant improvements in endometriosis- AbbVie
AbbVie has announced detailed results from two replicate pivotal Phase III clinical trials evaluating the efficacy and safety of elagolix in premenopausal women who suffer from endometriosis. The data demonstrate that, compared to placebo at month three and month six, patients treated with Elagolix reported statistically significant reductions in scores for menstrual pain (dysmenorrhea, DYS) and non-menstrual pelvic pain (NMPP) associated with endometriosis as measured by the Daily Assessment of Endometriosis Pain scale. In the two studies, both doses of Elagolix administered orally demonstrated a statistically significant improvement versus placebo in the percentage of DYS and NMPP responders.
In the first study, at month three, 46 percent of patients treated with 150 mg once daily and 76 percent of patients treated with 200 mg twice daily of Elagolix were classified as DYS responders, versus 20 percent of patients in the placebo group. Fifty percent of patients treated with 150 mg once daily and 55 percent of patients treated with 200 mg twice daily of Elagolix were classified as NMPP responders, versus 36 percent of patients in the placebo group. The safety profile of Elagolix was consistent across both Phase III trials and also consistent with prior Elagolix studies.
In the first study, the most frequently reported adverse events (AEs) assessed over six months were hot flush (7%, 24%, 42% for placebo, 150 mg once daily and 200 mg twice daily, respectively), headache (10%, 15%, 17% for placebo, 150 mg once daily and 200 mg twice daily, respectively), and nausea (14%, 10%, 16% for placebo, 150 mg once daily and 200 mg twice daily, respectively). As anticipated by its mechanism of action, some AEs, such as hot flush were dose-dependent. The second pivotal Phase III study demonstrated similar results. The results were presented at the 72nd American Society for Reproductive Medicine Scientific Congress & Expo.
Comment: AbbVie will complete the clinical database in anticipation of a New Drug Application submission for endometriosis in 2017.
Related news and insights
Amicus Therapeutics announced that the European Medicines Agency validated the Marketing Authorization Applications (MAA) for AT GAA (cipaglucosidase alfa + miglustat), the Company’s investigational two-component therapy for the treatment of Pompe disease.
Bristol Myers Squibb announced that the FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for Reblozyl (luspatercept-aamt), a first-in-class erythroid maturation agent, for the treatment of anemia in adults with non-transfusion dependent (NTD) beta thalassemia.
BeiGene, Ltd. and EUSA Pharma (UK), Ltd. announced that the China National Medical Products Administration (NMPA) has approved Sylvant (siltuximab for injection) for the treatment of adult patients with multicentric Castleman disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpes virus-8 (HHV-8) negative, also known as idiopathic MCD (iMCD).