The U.S. Food and Drug Administration (FDA) recently withheld approval for a novel once-a-month injection designed to treat relapsing forms of multiple sclerosis (MS), a severe neurological disorder.
This decision impacts the collaborative efforts of Viatris and Mapi Pharma, the developers behind this treatment, as disclosed on Monday.
The refusal by the FDA was communicated through a Complete Response Letter (CRL), advising that the current application does not meet the necessary approval criteria and requires additional information.
The specifics of the FDA’s concerns were not disclosed, but the companies have committed to reviewing the CRL closely to decide their future course of action.
This setback does not change Viatris’ financial outlook for 2024, with the company maintaining its projected new product revenue range of $450 million to $550 million.
The treatment in question, GA Depot, represents a long-acting formulation of glatiramer acetate, a drug already sanctioned for managing relapsing MS cases.
Unlike the existing treatment Copaxone by Teva Pharmaceutical Industries, which requires thrice-weekly administration, GA Depot is designed for once-a-month intramuscular injection, potentially offering significant convenience and compliance benefits to patients.
Viatris had secured the commercialization rights for GA Depot back in 2018 through an exclusive licensing agreement with Mapi Pharma, indicating a long-term investment in its development.
The refusal to approve the drug will necessitate a strategic reassessment and possibly further research by the companies to address the FDA’s concerns.
Multiple sclerosis is a debilitating condition where the body’s immune system erroneously attacks the brain’s nerve cells, leading to various motor disabilities.
It is estimated to affect around 400,000 individuals in the United States alone.
The disease manifests in several forms, with relapsing MS characterized by intermittent episodes of symptoms followed by periods of remission.
The development of treatments like GA Depot is critical in providing relief and improving the quality of life for those afflicted by this unpredictable and challenging disease.