Dosing Commenced in Study of Anti-Tau Agent, FDA Updates Labeling to Glatiramer Acetate Products, Eisai Initiates Rolling Submission for Subcutaneous Lecanemab

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Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

According to a new announcement, the first participants in a phase 1 study assessing Voyager Therapeutics’ anti-tau antibody VY-TAU01, an investigational agent in development for Alzheimer disease (AD), have been dosed. VY-TAU01 us an intravenously-administered, recombinant, humanized IgG4 monoclonal antibody designed to inhibit the spread of pathological tau, which is closely correlated with disease progression and cognitive decline in AD. The study, a single-ascending dose (SAD), double-blind, placebo-controlled trial, is conducted at a single center and is expected to enroll approximately 48 healthy volunteers in multiple cohorts. The belief is that results from this study will help inform the design of a phase 1b multiple ascending dose trial of patients with early AD, which Voyager expects to initiate in 2025. In addition, the company is expecting initial tau PET imaging data from the SAD to be released in the second half of 2026, which will help determine VY-TAU01’s true impact on pathological tau.

The FDA has issued an update to the labeling of glatiramer acetate injection products, with a new warning label that highlights cross-compatibility issues with the use of autoinjectors. In the update, the agency also alerted patients and health care professionals that some specific glatiramer acetate injection therapies may be administered using an optional compatible autoinjector, while other glatiramer acetate injection products must only be injected using the prefilled syringe. The increased risk for medications errors, such as a missed dose or administration of a partial dose, was the basis behind the updated labeling for these autoinjectors. The agency noted it will not further update the table of glatiramer acetate injection products and their optional compatible autoinjector devices included in the CDER Alert originally issued in August 2022.

A new formulation of lecanemab (Leqembi; Eisai), an FDA-approved therapy for early-stage Alzheimer disease (AD), may be on the way, according to Eisai, the drug manufacturers of the agent. In a new announcement, the company noted it initiated a rolling submission of a biologics license application (BLA) to the FDA for a subcutaneous autoinjector version of the drug for maintenance dosing, allowing easy administration of the therapy at home or at medical facilities. The BLA is based on data from the phase 3 Clarity AD trial (NCT03887455), otherwise known as the supportive trial that led to lecanemab’s approval, its open-label extension (OLE), and modeling of observed data. The subcutaneous autoinjector under review delivers 360 mg weekly maintenance dosing of lecanemab that takes less time than the intravenous (IV) formulation, the formulation it was originally approved in. It is intended to facilitate easier treatment of the drug, thus reducing the need for hospital visits and nursing care.

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