May 23, 2023 – The maker of blockbuster drugs Ozempic and Wegovy says a pill version produces similar weight reduction results and will probably be submitted for FDA approval later this yr.
Danish pharmaceutical company Novo Nordisk announced The results of the Phase III study for the pill, which accommodates the identical lively ingredient because the common injection variants, were published on Tuesday.
“The choice between a daily tablet or a weekly injection for obesity potentially offers patients and healthcare providers the opportunity to choose what best suits individual treatment preferences,” said Martin Holst Lange, MD, PhD, executive vp of development at Novo Nordisk, in a press release.
In a study of 667 chubby or obese people, those that took the semaglutide pill each day lost 17% of their body weight after 68 weeks. People who took a placebo pill lost 1.8% of their body weight over the identical period. The average starting weight of an individual within the study was 232 kilos, meaning the standard participant lost about 40 kilos over the nearly 6-year study.
The company said the semaglutide pill “appeared to have a safe and well-tolerated profile” and that essentially the most common uncomfortable side effects were gastrointestinal in nature, “mild to moderate in severity and resolved over time.”
The uncomfortable side effects were comparable to those seen in people taking Ozempic or Wegovy.
Ozempic is FDA-approved for individuals with type 2 diabetes and Wegovy is approved for weight management. Both weekly injections contain the drug semaglutide, but in several doses. The recent pill form is meant for weight management.
Both Wegovy and Ozempic are facing supply shortages within the U.S. because of rising demand. Novo Nordisk said it should seek FDA approval for the brand new pill version by the top of this yr. The company declined to comment on production capability. Reuters was reported, and it was also noted that Pfizer is developing an analogous oral semaglutide treatment for diabetes.
Semaglutide mimics a gut hormone called glucagon-like peptide-1 (GLP-1), which helps the brain regulate appetite and can even affect food cravings. Novo Nordisk already makes a semaglutide pill that’s FDA-approved for diabetics. The Rybelsus pill should be taken based on strict criteria and has shown only limited weight reduction in studies.