The U.S. Food and Drug Administration approved the tablet version of Novo Nordisk A/S' drug semaglutide, named Rybelsus, to manage blood sugar level in adult patients with type 2 diabetes.
Rybelsus is the first glucagon-like peptide receptor protein treatment approved in the U.S. that does not need to be injected, according to the FDA. The drug should be used as an add-on to diet and exercise.
Type 2 diabetes is the most common form of diabetes, occurring when the pancreas cannot make enough insulin to keep blood sugar at normal levels.
Novo Nordisk said the approval was backed by data from 10 Pioneer clinical trials. Rybelsus was shown to be better in clinical trials compared to Merck & Co. Inc.'s Januvia, or sitagliptin, and Eli Lilly and Co. and Boehringer Ingelheim GmbH's Jardiance, or empagliflozin, in reducing blood sugar levels.
The Denmark-based pharmaceutical giant said in a Sept. 20 press release that it expects to make Rybelsus available in the U.S. in the fourth quarter of 2019.
Earlier in September, the U.S. drug pricing watchdog Institute for Clinical and Economic Review had said in a draft report that the oral formulation of semaglutide appeared to be cost-effective when compared to Jardiance and Januvia, although its price has yet to be set.
