Novo Nordisk announced that the FDA issued a refusal-to-file letter related to its application to expand the label for once-weekly subcutaneous Ozempic (semaglutide).
The company had sought to expand the label for a 2.0-mg dose of once-weekly semaglutide to treat type 2 diabetes. It filed the letter on Jan. 20, 2021.
The letter indicates that FDA has concluded additional information is needed to review an application.
FDA requested information related to the new proposed manufacturing site for the drug.
Novo Nordisk stated that it believes it has sufficient data to warrant the label expansion application.
The company plans to resubmit the application to FDA in the second quarter of 2021.
The current FDA labeling recommends patients begin taking 0.25 mg of semaglutide once weekly, increasing to 0.5 mg after four weeks. Patients who require additional glycemic control can have the dose to 1 mg once weekly after an additional four weeks.
The current FDA label also states that semaglutide causes thyroid C-cell tumors in rodents, but it is unknown if the risk applies to humans.
The label contraindicates the drug for patients with a personal or family history of medullary thyroid carcinoma or patients with multiple endocrine neoplasia syndrome type 2.
Recent clinical trials also indicate that semaglutide can support weight loss when used in conjunction with behavior modification.