This Week at FDA: FDA approves first OTC syphilis test, final cancer drug dosage guidance, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, FDA approved an at-home syphilis test, announced a meeting to discuss the newly announced Rare Disease Innovation hub, and published a guidance on optimizing the dosage of cancer drug.

On Friday, FDA announced that it had approved NOWDiagnostics’ First to Know a-home, over-the-counter syphilis diagnostic test. The agency noted it was the first test of its kind to detect Treponema pallidum (syphilis) antibodies in human blood, and while it still requires a confirmatory follow-up test, it's a major advancement in addressing sexually transmitted infections.

Following up its launch of a Rare Disease Innovation Hub last month, and FDA has scheduled a public meeting on 16 October to discuss its goals. The Reagan-Udall Foundation for the FDA will facilitate the meeting at FDA's headquarters in Silver Spring, MD, but stakeholders can also participate virtually.

FDA finalized a guidance meant to help sponsors figure out the optimal dosage when developing cancer drugs. The agency noted, however, the guidance does not address how to select the starting dosage for first-in-human trials; dosage optimization for radiopharmaceuticals, cellular and gene therapy products, oncolytics, microbiota, or cancer vaccines, nor does it specifically address pediatric drug development.

FDA's Science Board is scheduled to meet on 7 October to get an update from the New Alternative Methods subcommittee about the agency's major reorganization plans that go into effect on 1 October. The reorganization includes a significant update to the role of the Office of the Chief Scientist and the creation of a unified Human Foods Program.

FDA announced it has extended the use of its Peripheral and Central Nervous System Drugs Advisory Committee for another two years. The panel of external experts will now continue to operate till at least 4 June 2026.

Stakeholders are being asked to give feedback on the abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of eight drug substances, including Hexahydrocannabinol, N-Pyrrolidino Protonitazene (Protonitazepyne), N-Pyrrolidino Metonitazene (Metonitazepyne), N-Piperidinyl Etonitazene (Etonitazepipne), N-Desethyl-isotonitazene, 3-Hydroxy-phencyclidine; N-Ethylheptedrone, and Carisoprodol by 23 August. FDA said the feedback will be considered in the US government’s response to the World Health Organization (WHO) on abuse liability and diversion of the drugs.

Drugs & Biologics

Incyte Corporation's Niktimvo (axatilimab-csfr), a colony-stimulating factor-1 receptor-blocking antibody, has been approved by FDA to treat chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in patients weighing at least 40kg. The drug was granted priority review, and the sponsor used the agency's Assessment Aid to get it across the finish line.

AstraZeneca’s cancer drug Imfinzi (durvalumab) was also approved by FDA as a neoadjuvant treatment with platinum-containing chemotherapy, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

Several biologics licensing application (BLA) supplements were approved by FDA, including Ferring Pharmaceuticals's request to have the hold time of the thawed version of its drug Adstiladrin (nadofaragene firadenovec-vncg) extended to seven days when refrigerated at 2°C to 8°C and 24 hours at room temperature. The agency approved the updated label for the biologic, which was already on the market to treat adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Octapharma's BLA supplement to expand the indication for its biologic Fibryga (fibrinogen) to include fibrinogen supplementation in bleeding adult and pediatric patients with acquired fibrinogen deficiency was approved by FDA. It was originally approved in 2017 to treat acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Medtech

FDA announced it has classified several medical devices into class II following de novo authorizations for products manufactured by Biofire Defense and Biofire Diagnostics, which operates under bioMerieux and in partnership with the US Army Medical Materiel Development Activity’s Warfighter Protection and Acute Care Project Management Office to detect certain tropical diseases and infections, it has given class II designation with special controls for tests to diagnose acute febrile illness and those used to identify nucleic acid targets in respiratory specimens from microbial agents that cause SARS-CoV-2.

The agency also designated intravenous catheter force-activated separation devices as class II devices with special controls after giving de novo authorization to Lineus Medical's SafeBreak Vascular. The device was designed to reduce mechanical complications with IV catheters.

Similarly, FDA wrote to Personal Genome Diagnostics that it has designated its PGDx elio plasma focus Dx, a prescription device, as a class II device. It also wrote to IntuiTap Medical to correct its regulation number from a 19 January classification order giving class II designation to its VerTouch Spinal Imaging Device.

FDA has extended the indication for Edwards Lifescience's Sapien 3, Sapien 3 Ultra, and Sapien 3 Ultra Resilia Transcatheter Heart Valve System to replace a failing, previously implanted surgical biological mitral valve in patients at intermediate or higher risk of complications or death from open heart surgery. The valves made from cow tissue had previously been approved to replace failing mitral valves in patients who are too high risk for open-heart surgery when the valve has already been repaired with a prosthetic ring or to treat severe narrowing of the aortic valve when the valve is the patient’s original valve.

This Week at FDA: FDA approves first OTC syphilis test, final cancer drug dosage guidance, and more

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