Mylan gets USFDA nod for multiple sclerosis drug

Partner Natco Pharma’s shares reach upper limit of 20%

Hand wearing surgical glove holding a syringe

Natco Pharma shares on Wednesday gained ₹159.05 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.

‘Most prescribed’

It is the ‘most prescribed’ treatment for relapsing forms of MS in the U.S. with brand sales for the 20 mg/mL dose of approximately $700 million; and for the 40 mg/mL dose, about $3.64 billion for the 12 months ended July 31, Natco said citing Quintiles IMS.

About 4,00,000 people in the U.S. have MS, and relapsing MS accounts for 85% of initial diagnoses. Natco Pharma said it would shortly communicate plans for unveiling of both products.

“Mylan has invested tens of millions of dollars over many years to bring this medicine to market,” CEO Heather Bresch said.