May 23, 2023 – The maker of blockbuster drugs Ozempic and Wegovy says a pill version produces similar weight reduction results and can be submitted for FDA approval later this 12 months.
Danish pharmaceutical company Novo Nordisk announced The results of the Phase III study for the pill, which comprises 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 vice chairman of development at Novo Nordisk, in a press release.
In a study of 667 chubby or obese people, those that took the semaglutide pill day by 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 probably the most common unwanted effects were gastrointestinal in nature, “mild to moderate in severity and resolved over time.”
The unwanted effects were much like 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. as a result of rising demand. Novo Nordisk said it can seek FDA approval for the brand new pill version by the tip of this 12 months. The company declined to comment on production capability. Reuters was reported, and it was also noted that Pfizer is developing an identical oral semaglutide treatment for diabetes.
Semaglutide mimics a gut hormone called glucagon-like peptide-1 (GLP-1), which helps the brain regulate appetite and also can affect food cravings. Novo Nordisk already makes a semaglutide pill that's FDA-approved for diabetics. The Rybelsus pill have to be taken in accordance with strict criteria and has shown only limited weight reduction in studies.