First Generic of MS Treatment Gets FDA Nod

The FDA today approved Sandoz's glatiramer acetate (Glatopa), a once-daily injection indicated for relapsing forms of multiple sclerosis.

The FDA today approved Sandoz’s glatiramer acetate (Glatopa), a once-daily injection indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), including those who have experienced a first clinical episode and have magnetic resonance imaging features consistent with MS.

The drug is the first approved generic of Teva’s MS treatment, Copaxone.

“Sandoz, together with Momenta, is proud to be the first company to receive FDA approval for a substitutable generic version of this important therapy,” said Sandoz US President Peter Goldschmidt in a press release. “The approval of Glatopa reinforces Sandoz leadership in complex, differentiated generic products and further demonstrates our commitment to offer patients and payers a full range of therapeutic options.”

The most common adverse events associated with the use of Glatopa were injection site reactions such as erythema, vasodilatation, rash, dyspnea, and chest pain (13% vs 6%). The drug is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. The disorder affects approximately 500,000 individuals in the United States, about half of whom remain untreated, according to a Sandoz press release.