- Natco Pharma gained apiece to hit the upper circuit limit of 20% on the back of USFDA approving marketing partner Mylan’s application for generic version of Teva’s Copaxone that is used in the treatment of multiple sclerosis (MS).
- The regulator had approved Mylan’s abbreviated new drug applications for Glatiramer Acetate injection 40 mg/ml (3-times-a-week injection) as well as Glatiramer Acetate Injection 20 mg/mL (once-daily injection), the Hyderabad-based firm said.
- The FDA has approved the products as therapeutic AP-rated equivalents to Copaxone, meaning if they are substituted for their branded counterpart they can be expected to have the same clinical effect and safety profile, Mylan N.V. said in its announcement late on Tuesday evening.
- Copaxone is indicated for treatment of patients with relapsing forms of multiple sclerosis, a chronic inflammatory disease of the central nervous system.
- It is the ‘most prescribed’ treatment for relapsing forms of MS in the U.S.
- About 4,00,000 people in the U.S. have MS, and relapsing MS accounts for 85% of initial diagnoses.