Eli Lilly and CompanyPositive efficacy data for Foundayo, EloraTZP and Ebglyss, plus FDA submissions for label expansion and type II diabetes approval.
Eli Lilly and Company presented new efficacy data from studies of its marketed and investigational metabolic medicines at the annual European Association for the Study of Diabetes conference. In the phase III ACHIEVE-4 study, Foundayo (orforglipron), a once-daily oral GLP-1 receptor agonist approved for chronic weight management, demonstrated a non-inferior risk of major adverse cardiovascular events versus titrated insulin glargine, with MACE-4 risk 16% lower, MACE-3 risk 23% lower, cardiovascular death risk 53% lower and all-cause death risk 57% lower; at 52 weeks A1C declined 1.6% versus 1% and body weight fell 8.8% versus a 1.7% increase, while 10.6% discontinued due to adverse events. Lilly also reported positive 48-week results from a phase IIb study of EloraTZP, an investigational combination of eloralintide and Zepbound, in adults with obesity or overweight and type II diabetes, where the highest-dose combination of 9 mg eloralintide plus 15 mg Zepbound reduced body weight by 23.3% (54.1 pounds) versus 14.8% (34.4 pounds) for Zepbound 15 mg alone, and A1C declined 2.9% versus 2.4%. Separately, the phase IIIb ADtouch study of Ebglyss (lebrikizumab-lbkz) met its primary and secondary endpoints, with 53% of patients on monotherapy achieving clear or almost clear hands and feet at week 16 versus 27% with placebo, and Lilly has submitted the data to the FDA seeking a potential U.S. label expansion to include localized atopic dermatitis with moderate-to-severe hand and foot involvement. Lilly has also submitted a regulatory filing to the FDA seeking approval of Foundayo for the treatment of type II diabetes, with the application currently under review, intensifying its oral GLP-1 competition with Novo Nordisk's oral Wegovy, Ozempic and Rybelsus.
Eli Lilly and CompanyPositive efficacy data for Foundayo, EloraTZP and Ebglyss, plus FDA submissions for label expansion and type II diabetes approval.
Viking Therapeutics Inc
Novo Nordisk A/SLilly's Foundayo type II diabetes filing intensifies oral GLP-1 competition with Novo Nordisk's oral Wegovy, Ozempic and Rybelsus.