FDA Approves First Generic Glatiramer Acetate and Pediatric Menkes Treatment in Q1 2026
The FDA approved ScinoPharm Taiwan's glatiramer acetate as the first complex injectable generic for relapsing multiple sclerosis and Sentynl Therapeutics' copper histidinate as the first treatment for pediatric Menkes disease in January 2026. These approvals represent significant advancements in neurological care, with the glatiramer acetate approval following a novel regulatory pathway and the Menkes treatment showing improved survival in early-treated patients.
The first quarter of 2026 saw significant progress in neurological care with multiple FDA approvals, including the first complex injectable generic for multiple sclerosis and the first treatment for pediatric Menkes disease. On January 5, 2026, the FDA approved ScinoPharm Taiwan's glatiramer acetate injection as a treatment for relapsing multiple sclerosis, making it the first complex injectable generic approval for this therapy. One week later, on January 12, 2026, the agency approved Sentynl Therapeutics' copper histidinate as the first treatment for pediatric patients with Menkes disease, a rare genetic neurodegenerative disorder.
The newly approved glatiramer acetate version is a nonbiological complex drug generic, meaning it has the same active ingredient, route of administration, and typical strengths of traditional GA, mirroring the Copaxone label. The product followed the nonbiological complex drug abbreviated new drug action pathway described in the FDA's product-specific guidance for GA, which allows waiving traditional clinical bioequivalence trials if the generic demonstrates tight structural and compositional matching, as well as in vitro and in vivo functional similarity.
Marketed as Zycubo, the copper histidinate therapy is a subcutaneous copper replacement treatment that delivers copper in a form designed to bypass impaired intestinal absorption and support systemic utilization of the mineral. The company resubmitted a revised new drug application for copper histidinate on November 14, 2025, following receipt of a complete response letter from the FDA on September 30, 2025. In the complete response letter, the agency cited observations related to current good manufacturing practice compliance at the manufacturing site, but no additional approvability concerns were identified, and the FDA did not note deficiencies in the efficacy or safety data.
The efficacy and safety data for copper histidinate showed improved overall survival among patients with Menkes disease who received early treatment. Beginning copper histidinate therapy in affected neonates has been shown to reduce symptoms and prolong life, according to clinical experts.
On February 4, 2026, the FDA granted premarket approval for Balt's Squid liquid embolic agent for embolization of the middle meningeal artery as an adjunct to usual care in patients with large symptomatic chronic subdural hematomas. The approval was based on results from the prospective, randomized STEM trial, which evaluated MMA embolization for chronic subdural hematomas and demonstrated a significant reduction in treatment failures in a large patient population.
The STEM trial demonstrated that adjunctive embolization of the MMA with Squid significantly reduced treatment failure rates without increasing adverse events in patients managed with either surgery or medical management. In the primary efficacy analysis, a primary outcome event occurred in 19 of 120 patients (16%) in the embolization group versus 47 of 129 patients (36%) in the control group, corresponding to a 64% relative reduction in risk.