FDA approves Novo Nordisk’s oral Type 2 diabetes drug

The drug, Rybelsus, is the first oral medication in the GLP-1 receptor agonist class. The approval was based on data from 10 trials that enrolled more than 9,500 patients.

The Food and Drug Administration has approved the first oral drug for Type 2 diabetes belonging to a widely used class of medications for the disease.

The agency announced on Friday the approval of Rybelsus (semaglutide), made by Bagsvaerd, Denmark-based drugmaker Novo Nordisk, for Type 2 diabetes, though it is not recommended as a first-line treatment. Rybelsus is the first GLP-1 receptor agonist that does not need to be injected. The company has marketed an injected form of semaglutide, Ozempic, since December 2017.

Shares of Novo Nordisk were up about 2.6 percent on the Copenhagen Stock Exchange and about 2 percent on the New York Stock Exchange Friday.

The approval is based on data from 10 trials in the Phase IIIa PIONEER program, which enrolled a total of 9,543 patients and randomized them to receive Rybelsus or Eli Lilly & Co.’s Jardiance (empagliflozin), Merck’s Januvia (sitagliptin), Novo Nordisk’s Victoza (liraglutide) or placebo. According to data from the trials, Rybelsus was able to reduce levels of A1C and also body weight among patients, which was a secondary endpoint, Novo Nordisk said. The company filed for FDA approval in March.

According to a March publication of data from the PIONEER 3 study, which compared Rybelsus against Januvia, Rybelsus at 7mg or 14mg daily – added to the drug metformin, with or without sulfonylurea – showed a statistically significantly greater reduction in A1C over 26 weeks. In PIONEER 2, Rybelsus also showed greater A1C reduction than Jardiance, according to data published this month.

Others have been developing oral GLP-1 receptor agonists as well. In September of last year, Lilly paid $50 million to Tokyo-based Chugai Pharmaceutical to license OWL833, described at the time as ready for Phase I development.

“Patients want effective treatment options for diabetes that are as minimally intrusive on their lives as possible, and the FDA welcomes the advancement of new therapeutic options that can make it easier for patients to control their condition, said Lisa Yanoff, who directs the Division of Metabolism and Endocrinology at the FDA’s Center for Drug Evaluation and Research, in a statement.

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