Sage confirms suspension of 2 depression trials after PhIII flop; Esperion follows up maiden approval with combo OK
→ In the wake of a flop in the crucial Phase III MOUNTAIN study, Sage Therapeutics confirmed in its quarterly update that it’s suspended enrollment in two other pivotal trials for the oral depression drug SAGE-217 (or zuranolone) as it awaits guidance from the FDA. While REDWOOD (measuring relapse) and RAINFOREST (for patients with both major depressive disorder and insomnia) are on hold pending amendments, though, the open-label SHORELINE has completed enrollment. CEO Jeff Jonas remained tight-lipped about what specific tweaks they are considering for the program, reiterating only there have been issues with compliance and room for a higher dose.
→ Esperion Therapeutics — fresh off the high of its maiden FDA approval for cholesterol-fighter bempedoic acid (branded Nexletol) last week — was widely expected to win the agency’s endorsement for the combination of bempedoic acid and ezetimibe (another cholesterol-lowering medicine). The combination therapy, christened Nexlizet, crossed the finish line late on Wednesday. Nexlizet will launch in July 2020, a few months after Nexletol launches.
→ Among other recommendations, the EMA on Friday backed two therapies: Boehringer Ingelheim‘s nintedanib for systemic sclerosis-associated interstitial lung disease, which was approved by the FDA last September; and Takeda‘s subcutaneous formulation of the biologic vedolizumab as a maintenance therapy in active ulcerative colitis or Crohn’s disease (the IV formulation is already approved in the US and Europe).