Novartis secures FDA approval for larger dosage of MS drug Glatopa

This article was originally published here

PBR Staff Writer Published 14 February 2018

Novartis’ Sandoz division has secured approval from the US Food and Drug Administration (FDA) for a larger dosage of its Glatopa drug to treat relapsing forms of multiple sclerosis (MS).

The approval is for Glatopa 40mg/mL as a fully-substitutable, AP-rated generic version of Teva Pharmaceutical Industries’ three times-a-week Copaxone 40mg/mL therapy (glatiramer acetate injection).

Glatopa was approved by the FDA in April 2015 as a 20mg/ml one-time-daily multiple sclerosis (MS) therapy and had been the only generic glatiramer acetate product on the market for more than two years.

Sandoz CEO Richard Francis said: “The approval and launch of Glatopa 40 mg/mL reinforces our leadership in delivering complex, differentiated generic products.

“We look forward to bringing this product to patients and healthcare professionals and providing a full range of patient support services for Glatopa through GlatopaCare.”

Glatopa was developed by Sandoz under a collaboration agreement with Momenta Pharmaceuticals and is manufactured in the US.

Momenta Pharmaceuticals said Glatopa 40mg/mL comprises the same active ingredients, route of administration, strength, and dosage form as the referenced product.

The company said that Glatopa 40mg/mL will deliver identical clinical effect and safety profile as three times-a-week Copaxone 40mg/mL, which is often, prescribed as a first-line therapy in newly diagnosed MS patients.

Momenta Pharmaceuticals president and CEO Craig Wheeler said: “This approval further validates the strength of our physicochemical and biological characterization capabilities.

“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.”

Image: Novartis headquarters in Basel, Switzerland. Photo: courtesy of Novartis AG.

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