| Veru says drug preserved lean mass in patients on WegovyVeru said this morning that its investigational drug enobosarm helped preserve lean mass in patients taking Wegovy, though some experts were skeptical that the topline results were adequate to prove the benefits of the drug.In a Phase 2b trial, older patients taking Wegovy and enobosarm lost on average 1.2% of lean mass after 16 weeks, compared with a 4.1% loss in patients taking Wegovy and placebo. Veru said this difference was statistically significant.The trial, which enrolled 168 patients, tested a 3-mg and 6-mg dose of enobosarm, but the company grouped all patients who took enobosarm together in the topline readout. Read more from STAT’s Elaine Chen.Liver diseaseAkero drug reverses liver scarring in study of severe MASH patientsAkero Therapeutics this morning reported strong results from a nearly two-year, placebo-controlled study showing its drug efruxifermin reversed liver scarring in patients with cirrhosis caused by the liver disease known as MASH.After 96 weeks, 39% of patients offered a 50-mg dose of efruxifermin showed a clinically meaningful reduction in liver fibrosis, or scarring, without other symptoms of MASH getting worse, compared to 15% of participants randomized to a placebo. Read more from STAT’s Adam Feuerstein.alzheimer’s diseaseFDA approves monthly maintenance dosing for LeqembiThe FDA has approved monthly maintenance dosing of Leqembi in patients with early Alzheimer’s disease. After using the drug, made by Eisai and Biogen, every two weeks for 18 months, patients can transition to half the dose every month. The idea is that the disease can still progress even after the plaques are cleared from the brain; Leqembi is thought to keep any re-accumulation at bay.This new approval is based on a Phase 2 study as well as modeling simulations that predicted maintenance dosing would maintain benefits of the therapy.There had been concern that FDA approvals could be halted by the Trump administration’s pause on certain activities across the federal government’s health and science agencies. Such fears appear not to have been borne out. from Healthcare Dive:UnitedHealth hikes number of Change cyberattack breach victims to 190 million The new estimate nearly doubles the company’s previous report of 100 million affected individuals, already the largest healthcare data breach ever reported to federal regulators. |
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