FDA Roundup: March 7, 2025

, /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• On Wednesday, the FDA approved Encelto (revakinagene taroretcel-lwey), an allogeneic encapsulated cell-based gene therapy for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel). MacTel is a rare progressive disease of the macula (portion of the eye that process sharp central vision), leading to degeneration of the photoreceptors which are specialized light-detecting cells in the back of the eye.

  Encelto is administered into the patient's eye during a single surgical procedure performed by a qualified ophthalmologist. Encelto works by expressing recombinant human ciliary neurotrophic factor, which is a factor that may promote the survival and maintenance of the macular photoreceptors.

• On Wednesday, the FDA expanded the indication for neffy (epinephrine nasal spray) to include children four years of age and older who weigh 15 to less than 30 kg. Neffy was approved in 2024 for the emergency treatment of type 1 allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh at least 30 kg (66 pounds). Neffy is the first FDA-approved nasal spray to treat anaphylaxis and the first epinephrine product for the treatment of anaphylaxis that is not administered by injection. Treatment for children four years of age and older who weigh 15 to less than 30 kg consists of a 1 mg dose of epinephrine per spray in a single-dose nasal spray. The most common adverse effects for this pediatric population include nasal discomfort, upper respiratory tract congestion, dry throat, nasal dryness and tingling. Read the updated prescribing information to learn more.

Additional Resources:

• FDA Newsroom 

Media Contact: FDA Office of Media Affairs, 301-796-4540 
Consumer Inquiries: 888-INFO-FDA 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration