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Viatris Welcomes FDA Date On Slow-Release Copaxone Product

Collaboration With Mapi Penned In 2018; Firm Plans Filing In Europe

 
• By Dean Rudge

Viatris and Mapi have moved a step closer to realizing the US launch of their 505(b)(2) once- monthly glatiramer acetate product, a follow-on to Teva’s Copaxone treatment for multiple sclerosis.

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• Source: Shutterstock

Viatris and partner Mapi Pharma are set to find out in the first quarter of 2024 whether they can move ahead with their proposed once-monthly glatiramer acetate product, a follow-on to Teva’s Copaxone treatment for multiple sclerosis, after the ‘GA Depot 40mg’ asset was accepted for review by the US Food and Drug Administration.

News of the filing follows Mapi Pharma unveiling in September last year positive top-line results from its GA Depot Phase III clinical trial assessing the efficacy, safety and tolerability of the product

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