HOLZKIRCHEN, Germany — Sandoz has received Food and Drug Administration approval for Glatopa, a treatment for multiple sclerosis (MS).
The Novartis subsidiary said Thursday that its product is the first generic version of Teva’s Copaxone (glatiramer acetate injection) 20 mg/ml once-daily MS therapy.
Glatopa, developed in collaboration with Momenta and made entirely in the United States, is indicated for the treatment of 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.
“Sandoz, together with Momenta, is proud to be the first company to receive FDA approval for a substitutable generic version of this important therapy,” stated Peter Goldschmidt, president of Sandoz US. “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 a half-million people in the United States alone, and only half of those diagnosed are currently treated, Sandoz reported.
The company added that Glatopa joins an MS portfolio that includes two approved therapies and one late-stage development compound.