Glenmark Pharma gets USFDA nod for multiple sclerosis drugs

Glenmark Pharmaceuticals informed the exchanges on Wednesday that it has been granted final approval by United States Food & Drug Administration (USFDA) for Dimethyl Fumarate delayed-release capsules, 120 mg and 240 mg, the generic version of Tecfidera delayed-release capsules, 120 mg and 240 mg, of Biogen, Inc.

The above-mentioned drug is indicated for the treatment of patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease as well as an active secondary progressive disease, in adults.

According to IMS Health, (IQVIA) sales data for the 12-month period ending August 2020, the Tecfidera delayed-release capsules, 120 mg, and 240 mg market achieved annual sales of approximately US$ 3.8 billion.

The company’s current portfolio consists of 164 products, authorised for distribution in the US marketplace, and around 46 ANDA’s pending approval with the US health regulator.

At 12.40 pm on Wednesday, the stock of Glenmark Pharmaceuticals was trading at Rs 488.50 per share, down by 0.36 per cent or Rs 1.75 per share on BSE, against a 0.78 per cent gain in the benchmark index. The 52-week high is recorded at Rs 572.70 and the 52-week low is Rs 168 on BSE.