FDA approves first interchangeable biosimilar insulin
The FDA approved Mylan's Semglee (insulin glargine-yfgn), the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Semglee is both biosimilar to, and interchangeable with (can be substituted for without the intervention of the prescriber), Lantus (insulin glargine). Semglee is the first interchangeable biosimilar product approved in the US for the treatment of diabetes, meaning that Semglee can be substituted for Lantus at the pharmacy level.
Approval of biosimilar insulin can provide patients with additional safe, high-quality, and potentially cost-effective options for treating diabetes. Biosimilars are biological products that are highly similar to, and have no clinically meaningful differences from, a biological product already approved by the FDA.
OTC nasal antihistamine approved
The FDA approved nonprescription Astepro (azelastine hydrochloride nasal spray, 0.15%) for seasonal and perennial allergic rhinitis for adults and children 6 years of age and older. The approval allows consumers an option for a safe and effective nasal antihistamine without requiring the assistance of a healthcare provider. The 0.1% strength of azelastine hydrochloride nasal spray remains a prescription product; it is indicated for perennial allergy in children 6 months to 6 years of age and for seasonal allergy for children ages 2 through 6.
Data showed that the OTC nasal spray is safe and effective for use in self-medication when used as directed. Azelastine can cause drowsiness; consumers using the product should avoid alcoholic drinks and be careful when driving a motor vehicle or operating machinery.
Astepro is a product of Bayer Healthcare.
Injectable semaglutide approved for chronic weight management
Wegovy (semaglutide) is now approved for chronic weight management in adults with obesity (body mass index [BMI] 30 or greater) or overweight (BMI 27 or greater) with at least one weight-related condition such as hypertension, type 2 diabetes mellitus (T2DM), or high cholesterol, used in conjunction with a reduced-calorie diet and an exercise regimen.
Wegovy is a once-weekly injectable glucagon-like peptide-1 (GLP-1) receptor agonist. Semaglutide was first approved as Ozempic for T2DM and risk reduction of major cardiovascular events, including myocardial infarction, stroke, and death in adults with T2DM with known heart disease. It was also approved in an oral form (Rybelsus) for T2DM.
Wegovy is a product of Novo Nordisk.
FDA approves new drug for Alzheimer disease
The FDA approved Biogen's Aduhelm (aducanumab) for the treatment of Alzheimer disease. It is the first novel treatment approved for Alzheimer disease since 2003 and is a first-of-its-kind treatment (amyloid beta-directed antibody). Clinical trials for Aduhelm were the first to show that a reduction in plaques is expected to lead to a reduction in the clinical decline of this form of dementia.
The FDA's Peripheral and Central Nervous System Drugs Advisory Committee previously voted to overwhelmingly reject Aduhelm approval due to potential serious adverse reactions and lack of sufficient evidence that Aduhelm could slow cognitive decline in the disease's early stages.
The FDA said it decided to approve Aduhelm in the same way it makes regulatory decisions in situations where data are not straightforward. Ultimately, the agency opted to use the accelerated pathway, for which there is an expectation of clinical benefit despite some residual uncertainty about that benefit. The FDA will monitor Aduhelm as it is taken by more patients. A postapproval clinical trial will seek to verify the drug's clinical benefit.