From the first interchangeable Xolair biosimilar and a needle-free epinephrine spray for children, to the first liquid losartan formulation and an over-the-counter multi-STI home test, March’s FDA approvals reflect a focus on improving accessibility, administration, and therapeutic innovation across several specialties. Here is a comprehensive overview of the month's key FDA decisions.
Allergy and Immunology
FDA Approves First Interchangeable Biosimilar to Xolair
The FDA approved Omlyclo, the first interchangeable biosimilar to omalizumab (Xolair), for allergic asthma, chronic spontaneous urticaria, nasal polyps, and food allergy. Indications include patients aged one year and older, depending on condition. Omlyclo binds to immunoglobulin E and is administered subcutaneously. It carries a boxed warning for anaphylaxis and is approved for use in health care settings equipped to manage allergic reactions.
FDA Approves Intranasal Epinephrine for Pediatric Anaphylaxis
The FDA approved neffy 1 mg, the first needle-free, intranasal epinephrine spray for children aged four years and older weighing 15 kg to less than 30 kg. Approval was based on data showing pharmacokinetic and pharmacodynamic equivalence to injectable formulations. Neffy is expected to be available in the U.S. by May 2025.
Cardiology
FDA Approves First Liquid Formulation of Losartan
The FDA approved Arbli (losartan potassium) oral suspension, the first ready-to-use liquid losartan formulation in the U.S. Arbli is indicated for hypertension in patients aged six years and older, stroke risk reduction, and diabetic nephropathy in select patients with type 2 diabetes. The formulation eliminates the need for compounding and is expected to launch in the third quarter of 2025.
FDA Expands Vutrisiran Indication for ATTR Cardiomyopathy
The FDA approved vutrisiran (Amvuttra) to reduce cardiovascular death, hospitalizations, and urgent heart failure visits in adults with transthyretin-mediated amyloidosis with cardiomyopathy. Approval was based on HELIOS-B trial data demonstrating improved survival and reduced events. Vutrisiran is the first RNA interference therapy approved for both cardiomyopathy and polyneuropathy in this population.
Gastroenterology
FDA Approves Guselkumab for Crohn’s Disease
The FDA approved guselkumab (Tremfya), an interleukin-23 inhibitor (IL-23), for adults with moderately to severely active Crohn’s disease. Approval was supported by GRAVITI and GALAXI trials showing clinical and endoscopic remission with both subcutaneous and intravenous induction regimens. Guselkumab is the first IL-23 inhibitor with both delivery options for this indication.
Hematology
FDA Approves Qfitlia for Hemophilia A and B
The FDA approved fitusiran (Qfitlia) for prophylaxis in patients aged 12 years and older with hemophilia A or B, with or without inhibitors. The small interfering RNA therapy is dosed every two months and guided by antithrombin activity. Approval was based on trial data showing a greater than 70 percent reduction in bleeding rates. Qfitlia carries boxed warnings for thrombosis and gallbladder disease.
Infectious Diseases
FDA Approves First-in-Class Oral Antibiotic for UTIs
The FDA approved gepotidacin (Blujepa) for uncomplicated urinary tract infections in females aged 12 years and older. The first oral antibiotic with a novel mechanism of action for urinary tract infections in nearly 30 years, gepotidacin met noninferiority in one trial and superiority in another versus nitrofurantoin. Launch is anticipated in late 2025.
FDA Authorizes First OTC Multi-STI Test
The FDA authorized the Visby Medical Women’s Sexual Health Test, the first over-the-counter home test for chlamydia, gonorrhea, and trichomoniasis. The device provides results in 30 minutes using a self-collected swab and connected mobile app. Authorization was granted via the De Novo pathway, establishing a new classification for future tests.
Neurology
FDA Approves Tenecteplase for Acute Ischemic Stroke
The FDA approved tenecteplase (TNKase) for the treatment of acute ischemic stroke in adults, the first approval of a new stroke thrombolytic in nearly 30 years. The agent is administered as a single five-second intravenous bolus and demonstrated comparable safety and efficacy to alteplase in the AcT trial.
Obstetrics and Gynecology
FDA Approves First New Copper IUD in Four Decades
The FDA approved Miudella, a hormone-free copper intrauterine device for pregnancy prevention for up to three years. It is the first new copper IUD approved in the U.S. in over 40 years. Clinical trial data showed 99% efficacy. The device will be available in 2025 under a Risk Evaluation and Mitigation Strategy program.
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