Lupin gets USFDA nod to market drug for treating relapsing multiple sclerosis

The company has received approval from the United States Food and Drug Administration (USFDA) to market its Dimethyl Fumarate delayed-release capsules in the strengths of 120 mg and 240 mg, Lupin said in a statement. The product is a generic version of Biogen Inc's Tecfidera delayed-release capsules in the same strengths, it added.

Drug firm Lupin on Tuesday said it has received approval from the US health regulator to market generic Dimethyl Fumarate delayed-release capsules used for treatment of relapsing forms of multiple sclerosis in adults. The company has received approval from the United States Food and Drug Administration (USFDA) to market its Dimethyl Fumarate delayed-release capsules in the strengths of 120 mg and 240 mg, Lupin said in a statement.

The product is a generic version of Biogen Inc's Tecfidera delayed-release capsules in the same strengths, it added. The company expects to launch the product shortly, the statement said. According to the IQVIA MAT June 2020 data, Dimethyl Fumarate delayed-release capsules had an annual sales of approximately USD 3,788 million in the US, Lupin said.

The capsules are indicated, "for the treatment of patients with relapsing forms of multiple sclerosis (MS) , to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults," it added. Shares of Lupin Ltd were trading at Rs 1,043.85 per scrip on the BSE, up 0.49 per cent over previous close.