USFDA declines to approve Viatris-Mapi Pharma's monthly multiple sclerosis injection

The companies were seeking the FDA's nod for GA Depot, a long-acting version of glatiramer acetate, which is approved for relapsing forms of MS.;

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-03-12 06:26 GMT | Update On 2024-03-20 10:45 GMT

The U.S. FDA has declined to approve Viatris and Mapi Pharma's once-a-month injection for treating relapsing forms of debilitating neurological condition multiple sclerosis (MS), the companies said.

The companies were reviewing the content of the health regulator's so called complete response letter (CRL) and would soon determine the appropriate next steps, they said, without disclosing further details.

Mapi Pharma did not immediately respond to Reuters requests for additional details on the contents of the CRL, which indicates that an application would not be approved in its present form and requires more information.

The companies were seeking the FDA's nod for GA Depot, a long-acting version of glatiramer acetate, which is approved for relapsing forms of MS.

GA Depot was being studied to be administered as an intramuscular injection once every four weeks, where as Teva Pharmaceutical Industries' glatiramer acetate injection, Copaxone, is given thrice a week.

Viatris acquired the commercialization rights to GA Depot through its exclusive license agreement with Mapi Pharma in 2018.

The receipt of the FDA's letter would not impact Viatris' 2024 forecast or its new product revenue range of $450 million to $550 million, the company said.

In MS, the immune system attacks brain cells, causing motor disabilities. It affects about 400,000 people in the United States, according to the National Institutes of Health.

Relapsing MS is a type of the disease where the symptoms appear sporadically, in the form of attacks. This is followed by a period of disease inactivity and weeks, months, or even years may pass before another attack occurs.

Original news source: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-declines-approve-viatriss-injection-multiple-sclerosis-2024-03-11/#:~:text=March 11 (Reuters) - The,the companies said on Monday.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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USFDA declines to approve Viatris-Mapi Pharma's monthly multiple sclerosis injection

The companies were seeking the FDA's nod for GA Depot, a long-acting version of glatiramer acetate, which is approved for relapsing forms of MS.;

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