Week in Review: Wegovy’s Cardio Benefits, Biosimilars Gather Momentum and More
Pictured: An elderly man with his hand over his heart/iStock, Rawpixel
It’s not often that I use the words “wonder drug” but I’m getting close when it comes to describing Novo Nordisk’s Wegovy (semaglutide). Friday, the Danish pharma touted results of a Phase III trial showing that patients with a common form of heart failure and obesity who took the once-weekly injection experienced improvements in fatigue and shortness of breath, as well as walked longer distances.
This is the second trial this month that has demonstrated Wegovy’s ability to improve heart health. A little over two weeks ago, Novo released results from a landmark study showing that its weight-loss drug cut the risk of major cardiovascular complications by 20% in overweight and obese adults without diabetes. And earlier this month, a Novo-funded study also pointed to the potential of semaglutide treatment to substantially reduce cardiovascular events.
Semaglutide mimics the GLP-1 hormone that targets areas of the brain that regulate appetite and food intake. GLP-1 agonists, a class of drugs that includes not just Wegovy but also Novo products Ozempic and Rybelsis as well as Eli Lilly’s Mounjaro, have also shown potential to treat nonalcoholic fatty liver disease, Alzheimer’s disease and perhaps addiction. At the same time, Novo and Eli Lilly are being sued over allegations that stomach paralysis could stem from treatment with these drugs, while other safety concerns have emerged including suicidal ideation.
This week we also saw continued evidence of a biosimilar onslaught amid the industry’s steep patent cliff, in which several drugs are losing exclusivity by the end of 2023. CVS Health announced Wednesday that it is joining the growing biosimilars market in the U.S. with its new subsidiary Cordavis, which will market a Humira biosimilar as its first product.
Also on the biosimilars front, the FDA on Thursday approved Sandoz’s Tyruko, the first biosimilar of Biogen’s blockbuster Tysabri for treating relapsing multiple sclerosis in adults. Tysabri, which has already taken a substantial sales hit this year, now has a serious competitor in the MS market.
Another noteworthy FDA approval this week happened on Monday when the regulator gave the greenlight to Pfizer’s RSV vaccine for expectant mothers. The shot, given during the third trimester of pregnancy, is designed to protect newborn babies through the first six months of life.