Over the past few months, several new diabetes treatments have been approved by FDA. Here are the top 3 novel drugs for diabetes:
- Insulin lispro injection (Admelog, Sanofi-Aventis), the first short-acting insulin approved as a “follow-on” product, is indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus.
Admelog was approved through an abbreviated approval pathway, the 505(b)(2) pathway, under the Federal Food, Drug, and Cosmetic Act. A new drug application submitted through this pathway may rely on FDA’s finding that a previously approved drug is safe and effective or on published literature to support the safety and/or effectiveness of the proposed product, if such reliance is scientifically justified.
“One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives. This is particularly important for drugs like insulin that are taken by millions of Americans every day for a patient’s lifetime to manage a chronic disease,” said FDA Commissioner Scott Gottlieb, MD, in a statement from FDA.
2. Bydureon BCise injectable suspension (AstraZeneca), a new formulation of Bydureon, is a once-weekly, single-dose autoinjector device to improve glycemic control in adults with type 2 diabetes.
“The new formulation in the innovative Bydureon BCise device is proven to reduce blood sugar levels, with the added benefit of weight loss,” AstraZeneca said in a statement provided to FormularyWatch.
Unlike other glucagon-like peptide-1 (GLP-1) receptor agonists, Bydureon BCise has a unique, continuous-release microsphere delivery system designed to provide consistent therapeutic levels of the active ingredient, exenatide, to help patients reach and maintain steady state, according to the statement.
3. Semaglutide (Ozempic, Novo Nordisk) injection 0.5 mg. or 1 mg., a once-weekly glucagon-like peptide (GLP-1) receptor agonist, expected to launch in the first quarter of this year, is prescribed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
As a secondary end point in clinical trials, treatment with Ozempic resulted in reductions in body weight. Ozempic is administered once weekly, on the same day each week, and can be taken any time of the day—with or without meals.
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 copays for eligible commercially insured patients, Novo Nordisk said in a statement. In addition, “Novo Nordisk is working with appropriate health insurance providers to establish innovative contracting solutions,” the statement said.