FDA Roundup: February 17, 2023

FDA News Release

• For Immediate Release: February 17, 2023

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

• On Thursday, the FDA approved Lamzede (velmanase alfa) the first enzyme replacement therapy approved in the U.S. for the treatment of non-central nervous system manifestations of alpha-mannosidosis, a rare genetic condition characterized by the lack of the alpha-mannosidase enzyme in the body. Lamzede acts the same way as the alpha-mannosidase enzyme in the human body thus restoring normal cellular activity in patients. The symptoms of alpha-mannosidosis vary, but often include mild to moderate intellectual disability, hearing loss, weakened immune system, distinctive facial features (e.g., a large head, prominent forehead, and protruding jaw), skeletal abnormalities and muscle weakness. Alpha-mannosidosis affects about 1 in every 500,000 people worldwide. The most common adverse reactions to Lamzede are hypersensitivity reactions including anaphylaxis, a severe, potentially life-threatening allergic reaction. See full prescribing information for additional information on the safety and effectiveness of Lamzede.
• On Wednesday, the FDA published the Medical Countermeasures Initiative (MCMi) Program Update report which showcases the FDA's critical role each year in protecting the United States from chemical, biological, radiological and nuclear threats, and emerging infectious diseases, like COVID-19 and mpox. This report provides updates on fiscal year 2022 activities FDA-wide to support medical countermeasure-related preparedness and response.
• On Tuesday, the FDA highlighted the new 2022 Food Code, which clarifies for the first time that food donations from retail food establishments are acceptable as long as proper food safety practices are followed. This addition in the Food Code is part of the Biden-Harris Administration’s National Strategy on Hunger, Nutrition and Health. The National Strategy provides a roadmap of actions the federal government will take to end hunger and reduce diet-related diseases by 2030 – all while reducing disparities. 
• COVID-19 testing updates: 
  • As of today, 444 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 molecular tests and sample collection devices, 85 antibody and other immune response tests, 58 antigen tests, and one diagnostic breath test. There are 78 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 26 EUAs for antigen over-the-counter (OTC) at-home tests, and four for molecular OTC at-home tests.
  • The FDA has authorized 43 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1236 revisions to EUA authorizations.