U.S. Food and Drug Administration (FDA) has approved Sandoz’s Abbreviated New Drug Application for Glatopa (glatiramer acetate injection) 40 mg/mL being developed under a collaboration agreement between Momenta and Sandoz in the US. Glatopa (glatiramer acetate injection) is indicated for the treatment of patients with relapsing-forms of multiple sclerosis.
Glatopa 40 mg/mL is FDA-approved as a fully substitutable, AP-rated generic version of three times-a-week COPAXONE 40 mg/mL therapy for patients with relapsing forms of multiple sclerosis (MS). In April 2015, the collaboration’s Glatopa 20 mg/mL product received FDA approval and remained the only generic glatiramer acetate product on the market for over two years.
Glatopa 40 mg/mL is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Glatopa 40 mg/mL, along with Glatopa 20 mg/mL, will offer patients a complete range of dosing options. Glatopa 20 mg/mL was made available in the US in June 2015. Patients can expect the same patient services for Glatopa 40 mg/mL as for Glatopa 20 mg/mL.
“This approval further validates the strength of our physicochemical and biological characterization capabilities,” said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “We are very proud to once again be able to provide patients with relapsing-forms of MS with a cost effective, high-quality generic alternative treatment option.”
Momenta will provide a corporate update, including an update on the approval and launch of Glatopa 40 mg, at the Leerink Partners 7th Annual Global Healthcare Conference on Thursday, February 15, 2018 at 10:00 a.m.