Medical uses
Glatiramer acetate is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.A 2010 Cochrane review concluded that glatiramer acetate had partial efficacy in "relapse-related clinical outcomes" but no effect on progression of the disease. As a result, it is approved by the FDA for reducing the frequency of relapses, but not for reducing the progression of disability.A 15-year followup of the original trial compared patients who continued with glatiramer to patients who dropped out of the trial. Patients with glatiramer had reduced relapse rates, and decreased disability progression and transition to secondary progressive MS, compared to patients who did not continue glatiramer. However, the two groups were not necessarily comparable, as it was no longer a randomized trial. There were no long-term safety issues. Adverse effects
Side effects may include a lump at the injection site (injection site reaction) in approximately 30% of users, and aches, fever, chills (flu-like symptoms) in approximately 10% of users. Side effect symptoms are generally mild in nature. A reaction that involves flushing, shortness of breath, anxiety and rapid heartbeat has been reported soon after injection in up to 5% of patients (usually after inadvertently injecting directly into a vein). These side effects subside within thirty minutes. Over time, a visible dent at a repeat-injection site can occur due to the local destruction of fat tissue, known as lipoatrophy, that may develop.
In October 2017, the FDA approved a generic version, which is manufactured in India by Natco Pharma, and imported and sold by Dutch firm Mylan. In February 2018, Sandoz received FDA approval for their generic version. In parallel with the development and approval processes, the generic competitors have disputed Tevas newer patents, any of which if upheld, would prevent marketing of long-acting generics.While the patent on the chemical drug expired in 2015, Teva obtained new US patents covering pharmaceutical formulations for long-acting delivery. Litigation from industry competitors in 2016-2017 resulted in the new patents being judged invalid. In October 2018, the U.S. Court of Appeals for the Federal Circuit upheld the patent invalidation for obviousness. The case reflects the larger controversy over evergreening of generic drugs. References
Further reading
"Glatiramer acetate". Drug Information Portal. U.S. National Library of Medicine.