FDA recently approved a new diabetes medication, as well as a drug to treat severe asthma.
FDA approved the New Drug Application (NDA) for semaglutide (Ozempic, Novo Nordisk) injection 0.5 mg or 1 mg, a once-weekly glucagon-like peptide (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Novo Nordisk expects to launch Ozempic in the United States in the first quarter of 2018, with a goal of “ensuring broad insurance coverage and patient access to the product,” the manufacturer said in a statement.
As such, Ozempic will be priced at parity to current market-leading weekly GLP-1 receptor agonists and will be offered with a savings card program to reduce co-pays for eligible commercially-insured patients. In addition, “Novo Nordisk is working with appropriate health insurance providers to establish innovative contracting solutions,” the company said.
Ozempic is administered once weekly, on the same day each week, and can be taken any time of the day, with or without meals.
The approval of Ozempic is based on the results from a phase 3a clinical trial program. Ozempic demonstrated clinically meaningful and statistically significant reductions in A1c compared with placebo, sitagliptin and exenatide extended-release.
As a secondary end point in the trials, treatment with Ozempic resulted in reductions in body weight.
Semaglutide is currently under review by the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.
Meanwhile, FDA also okayed benralizumab (Fasenra, MedImmune and AstraZeneca) for the add-on maintenance treatment of patients with severe asthma and with an eosinophilic phenotype.
The drug will be available in the US in the coming weeks, according to a statement from AstraZeneca.
“We’re excited to offer Fasenra as a new precision biologic to help improve the lives of severe asthma patients whose disease is driven by eosinophilic inflammation,” said Pascal Soriot, CEO of AstraZeneca, in the statement.
The FDA approval is based on results from the WINDWARD program, which included three phase 3 clinical trials. Results for the 8-week benralizumab dosing regimen from the trials demonstrated up to 51% reduction in the annual asthma exacerbation rate (AAER) versus placebo, as well as a significant improvement in lung function as measured by forced expiratory volume in one second (FEV1) of up to 159 mL. versus placebo.
In addition, patients taking benralizumab realized a 75% median reduction in daily oral corticosteroid (OCS) use and discontinuation of OCS use in 52% of eligible patients.