FDA Roundup: June 25, 2024

SILVER SPRING, Md., June 25, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

On Monday, the FDA issued a Small Entity Compliance Guide to assist small entities in complying with the FDA’s regulations as they apply to in vitro diagnostic (IVD) products, including laboratory developed tests (LDTs). The LDT Final Rule published on May 6, 2024, amends the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act including when the manufacturer of the IVD is a laboratory. Along with this amendment, the LDT Final Rule includes a policy under which FDA will phase out its general enforcement discretion approach for LDTs over the course of four years so that IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs. The phaseout includes targeted enforcement discretion policies for specific categories of IVDs manufactured by laboratories.

On Friday, the FDA issued a new report, New Drugs Regulatory Program Modernization – Impact Narrative Update 2023. In 2017, CDER began an initiative to modernize its New Drugs Regulatory Program (NDRP), to continuously improve regulatory science and review. This report provides a detailed look at the strategic objectives and impact of NDRP modernization progress, as well as on continued efforts toward reaching program goals. For more information about NDRP modernization efforts, please see this CDER Conversation with Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs.

On Friday, the FDA converted Sirturo (bedaquiline) to traditional approval following a determination that a confirmatory trial verified clinical benefit. Sirturo is indicated for pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid, also known as multi-drug resistant tuberculosis (MDR-TB), as part of a combination therapy, for adults and pediatric patients (5 years and older, weighing at least 15 kg). Sirturo was first approved in December 2012 under the FDA’s Accelerated Approval pathway. As part of the initial approval, the FDA required the applicant to conduct a confirmatory clinical study and develop a patient registry to assess rates of serious adverse events.

On Friday, the FDA granted accelerated approval to Krazati (adagrasib) plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. The most common adverse reactions (≥20%) were rash, nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, headache, dry skin, abdominal pain, decreased appetite, edema, anemia, cough, dizziness, constipation, and peripheral neuropathy. Full prescribing information for Krazati will be posted on Drugs@FDA.

On Friday, the FDA approved Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. CIDP is a rare type of immune-mediated, inflammatory, peripheral nerve disorder that affects the myelin sheaths – the fatty coverings on the fibers that insulate and protect the nerves. Symptoms of CIDP include progressive weakening of the arms and legs, numbness and tingling, impaired balance, and difficulty walking.

Vyvgart Hytrulo was previously approved for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. The most common adverse reactions (≥ 10%) of patients with gMG treated with Vyvgart were respiratory tract infections, headache, and urinary tract infection. Injection site reactions were also present (≥ 15%) in patients with CIDP who were treated with Vyvgart Hytrulo.

On Thursday, the FDA posted a grant opportunity to develop cooperative agreement(s) with academic research institutions to establish Animal and Veterinary Innovation Centers. This effort is part of the FDA’s ongoing commitment to encourage development of innovative products to better support animal health and veterinary interventions, including those that prevent, control, or eliminate Highly Pathogenic Avian Influenza virus in animals, or interventions that reduce the circulation of the virus in the ecosystem.

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.

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SOURCE U.S. Food and Drug Administration