FDA approves Sandoz’s Glatopa for multiple sclerosis treatment

The US Food and Drug Administration (FDA) has granted approval for Sandoz’s Glatopa, the first generic version of Teva’s Copaxone (glatiramer acetate injection) 20mg/ml one-time-daily multiple sclerosis (MS) therapy.

Developed in collaboration with Momenta and produced entirely in the US, Glatopa is indicated to treat patients with relapsing forms of MS, including those who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with MS, a debilitating disease.

Sandoz US president Peter Goldschmidt said: "Sandoz, together with Momenta, is proud to be the first company to receive FDA approval for a substitutable generic version of this important therapy.

"The approval of Glatopa reinforces Sandoz leadership in complex, differentiated generic products and further demonstrates our commitment to offer patients and payors a full range of therapeutic options."

MS affects about half a million individuals in the US alone; only half of those diagnosed are currently treated.

According to Sandoz, a Novartis company, glatiramer acetate is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.

Sandoz’s Glatopa joins a broad MS portfolio including two approved therapies and one late-stage development compound.