New Semaglutide Dosage Forms Approved by FDA

September 23, 2019

Now approved in 7mg and 14 mg tablets.

The FDA has approved new dosage forms of Novo Nordisk’s semaglutide (Rybelsus) tablets for type-2 diabetes. 

7 mg and 14 mg tablets are now available for the treatment of patients with type 2 diabetes that, along with diet and exercise, are believed to improve blood glucose levels. Semaglutide was originally approved by the FDA in 2017 the first glucagon-like peptide-1 (GLP-1) analog in a pill for the treatment of patients with type 2 diabetes who are not achieving their A1C goals with current antidiabetic treatments. 

“GLP-1 receptor agonists are effective medications for people with type 2 diabetes but have been underutilized in part because they have, until now, only been available as an injectable treatment,” says Vanita R. Aroda, MD, Director of Diabetes Clinical Research, Brigham and Women's Hospital, Boston, MA and a PIONEER clinical trial investigator in a statement. “The availability of an oral GLP-1 receptor agonist represents a significant development and primary care providers, specialists and patients alike may now be more receptive to the use of a GLP-1 therapy to help them achieve their blood sugar goals.”

Trending: Generics and Biosimilars Facing Formulary Difficulties

Boxed warning for semaglutide include the potential development of thyroid C-cell tumors. According to a release, the tumors developed in rodent trials, but the potential for c-cell tumor development in humans with the use of semaglutide is still unknown. 

Semaglutide is also contraindicated in patients with a personal or familial history of MTC or in patients with multiple endocrine neoplasia syndrome type 2, according to a boxed warning in the product’s prescribing information. 

Other warnings issued with the use of semaglutide include the potential for pancreatitis, diabetic retinopathy complications, hypoglycemia, acute kidney injury, and hypersensitivity reactions. 

Adverse reactions reported with the use of semaglutide include nausea, abdominal pain, diarrhea, decreased appetite, vomiting, and constipation.

Full Prescribing Information