This week our Healthcare Industry Insights focuses on a new approval indication for Novo Nordisk’s Wegovy, a pending decision on donanemab for Alzheimers, and potential withdrawal of the ALS drug, Relyvrio.
Semaglutide is the first weight loss treatment to be approved by the Food and Drug Administration (FDA) to help prevent cardiovascular death, heart attack and stroke in adults with cardiovascular disease who are obese or overweight. This decision is based on Novo Nordisk’s SELECT cardiovascular outcomes trial which demonstrated a reduction in the risk of adverse cardiovascular events by 20% compared with placebo. The cardiovascular benefits of semaglutide lasted up to five years.
FDA delays decision on Eli Lilly’s drug donanemab
Lilly’s donanemab was expected to receive a full approval from the FDA for the treatment of early-stage Alzheimer’s disease. However, the FDA has delayed its decision to discuss the safety and efficacy of donanemab with outside experts. This is the second delay, with donanemab failing to achieve accelerated approval last year. Donanemab aims to be the second FDA approved amyloid plaque targeting drug, with Leqembi by Eisai and Biogen receiving approval last year.
Amylyx has announced topline results from the Phase III PHOENIX trial. PHOENIX did not meet its primary or secondary endpoints. Relyvrio was approved by the FDA in 2022 for the treatment of ALS (Amyotrophic Lateral Sclerosis) based upon the results of the Phase II CENTAUR trial. This showed that Relyvrio slowed progression and functional decline and extended survival. Based on these recent results, Amylyx will stop promotions of the drug and will consider withdrawing the drug from the market.
