There was a time not that long ago when Merck & Co. Inc.’s Keytruda (pembrolizumab), with its multiple cancer indications, was seen as the heir apparent to Humira’s title of the biggest blockbuster drug. Not anymore. That title now belongs to Novo Nordisk A/S’ semaglutide, approved as Ozempic in 2017 to treat diabetes and as Wegovy in 2021 to help with weight loss.
Eli Lilly and Co. is planning to file for U.S. FDA approval later this year after reporting that tirzepatide met all primary and key secondary endpoints in two phase III trials in obstructive sleep apnea (OSA). Assuming approval, tirzepatide could become the first drug approved specifically for OSA, while providing potential entry access for Medicare Part D coverage, which is denied for the GLP-1 class of drugs approved as obesity medications.
When it comes to whether Medicare Part D should cover the new anti-obesity drugs, the U.S. Centers for Medicare & Medicaid Services and lawmakers may be caught between the math and public pressure.
Bioage Labs Inc.’s $170 million series D financing will pay for phase II trials with azelaprag, an apelin receptor agonist, to be tried in combination with Zepbound (tirzepatide), the glucose-dependent insulinotropic polypeptide receptor and glucagon-like peptide-1 (GLP-1) receptor agonist from Bioage partner Eli Lilly and Co.
Altimmune Inc.’s peptide-based glucagon-like peptide-1/glucagon dual receptor agonist pemvidutide hiccupped in a phase I study earlier this year but has bounced back with top-line results from its phase II study in obesity. Results showed robust reductions in body mass index and serum lipids, along with improvements in blood pressure with no imbalances in cardiac events, arrhythmias or clinically meaningful increases in heart rate. The data showed liver-fat loss similar to Novo Nordisk A/S’ GLP-1 drug Wegovy (semaglutide).
Astrazeneca plc will pay up to $2 billion for Eccogene Co. Ltd.’s oral weight loss candidate, ECC-5004, as big and small pharma players alike work to gain ground in the burgeoning obesity market where Eli Lilly and Co. scored the latest U.S. FDA approval of Zepbound (tirzepatide).
Astrazeneca plc will pay up to $2 billion for Eccogene Co. Ltd.’s oral weight loss candidate, ECC-5004, as big and small pharma players alike work to gain ground in the burgeoning obesity market where Eli Lilly and Co. scored the latest U.S. FDA approval of Zepbound (tirzepatide).
A year-and-a-half after Eli Lilly and Co.’s Mounjaro (tirzepatide) gained U.S. FDA approval for adults with type 2 diabetes, the GLP-1 and GIP dual agonist was cleared for chronic weight management in adults who are obese or overweight and who also have one related condition.