Lupin gets USFDA nod for drug to treat Multiple Myeloma

Lupin has bagged the approval for Lenalidomide capsules, the bioequivalent to Revlimid capsules manufactured by Bristol-Myers Squibb Company.

This drug is used to treat patients with Multiple Myeloma (MM), in combination with dexamethasone. It is also used in cases of Multiple Myeloma, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT).

In an exchange filing, the company announced that it has received approval for its Lenalidomide Capsules, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg from the United States Food and Drug Administration (USFDA).

Lenalidomide has an estimated annual sales of $7.5 billion in the US, and will be manufactured at Lupin’s Pithampur facility.

It is also used in cases of transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.

Earlier today, the Mumbai-based drugmaker was in focus as the USFDA  issued six observations for the company's Nagpur injectable facility.

In a statement on the matter, the company said, "We will address the observations and respond to the USFDA within the stipulated timeframe. We are committed to be compliant with current good manufacturing practices (CGMP) quality standards across all our facilities." As a result of this, the company's shares have traded in the red.

Shares of Lupin are down 0.67% or ₹13.70 per share. In the past month of trade, the company's shares have increased in value by 3.55%. The current stock price stands at ₹2,038.10 per share.

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