FDA Approvals Summary - March 2025

OMLYCLO

Approval Date: 03/07/2025

Active Ingredient: OMALIZUMAB-IGEC

Company: CELLTRION INC

Omlyclo is an anti-IgE antibody and the first interchangeable biosimilar to Xolair (omalizumab), approved for the treatment of multiple conditions:

• 1. Moderate to Severe Persistent Asthma: For adults and pediatric patients aged 6 years and older with asthma not adequately controlled with inhaled corticosteroids and who are reactive to perennial allergens. Omlyclo reduces frequency and severity of asthma attacks.
• 2. Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): As add-on maintenance treatment for adults 18+ whose CRSwNP is not adequately controlled by intranasal corticosteroids. It reduces polyp size and improves symptoms.
• 3. IgE-Mediated Food Allergy: For adults and children aged 1+, in combination with food allergen avoidance. It helps reduce risk of Type I hypersensitivity reactions from accidental exposure.
• 4. Chronic Spontaneous Urticaria (CSU): For adults and adolescents aged 12+ with CSU not adequately controlled with H1 antihistamines. Omlyclo reduces outbreaks and severity.

ARBLI

Approval Date: 03/13/2025

Active Ingredient:LOSARTAN POTASSIUM

Company: SCIENTURE LLC

FDA approved SCN-102, marketed as Arbli? (losartan potassium) oral suspension 10 mg/mL, the first and only ready-to-use liquid losartan in the U.S. market. Launch expected Q3 2025.

TYENNE

Approval Date: 03/14/2025

Active Ingredient:TOCILIZUMAB-AAZG

Company: FRESENIUS KABI USA

Tyenne, a biosimilar to Actemra (tocilizumab), is approved for IV and SC use. It treats:

• Moderate to severe active rheumatoid arthritis in adults not responding to DMARDs
• Giant cell arteritis in adults
• Polyarticular and systemic juvenile idiopathic arthritis in patients aged 2+

Approval supported by a Phase 3 study showing equivalent efficacy and safety to EU-approved tocilizumab.

GOZELLIX

Approval Date: 03/20/2025

Active Ingredient: KIT FOR PREPARATION OF GALLIUM GA 68 GOZETOTIDE

Company: TELIX INNOVATIONS SA

Gozellix? (Ga-68 labeled) is approved for PET imaging of PSMA-positive lesions in prostate cancer patients with suspected metastasis or recurrence. It features a 6-hour shelf life and extended distribution radius.

BLUJEPA

Approval Date: 03/25/2025

Active Ingredient: GEPOTIDACIN MESYLATE

Company: GLAXOSMITHKLINE LLC

Blujepa is a first-in-class oral antibiotic for treatment of uncomplicated urinary tract infections (uUTI) in adults and adolescents aged 12+. It targets two type II topoisomerases, reducing likelihood of resistance development. Approval based on positive results from EAGLE?2 and EAGLE?3 Phase 3 trials.

BOMYNTRA

Approval Date: 03/25/2025

Active Ingredient: DENOSUMAB-BNHT and CONEXXENCE / DENOSUMAB-BNHT

Company: FRESENIUS KABI USA LLC

FDA approved biosimilar denosumab-bnht for all indications of Prolia and Xgeva. Indications include osteoporosis in postmenopausal women, men, and patients on corticosteroids for 6+ months.

VYKAT XR

Approval Date: 03/26/2025

Active Ingredient:DIAZOXIDE CHOLINE

Company: SOLENO THERAPEUTICS INC

Vykat XR (formerly DCCR) is the first approved treatment for hyperphagia in Prader-Willi Syndrome (PWS) in adults and children 4+. It’s a once-daily extended-release formulation that regulates appetite through KATP channel activation. Approval based on a randomized withdrawal Phase 3 trial.

Qfitlia

Approval Date: 03/28/2025

Active Ingredient: Fitusiran

Company: SANOFI

Qfitlia, an siRNA therapy, is approved to reduce bleeding frequency in Hemophilia A or B patients (with or without inhibitors). It uses Alnylam’s ESC-GalNAc conjugation for improved subcutaneous efficacy. FDA also approved INNOVANCE? antithrombin test as companion diagnostic. Qfitlia testing will be provided free via Labcorp collaboration.