New Delhi: Drug firm Glenmark Pharmaceuticals on Tuesday said it has received orphan drug designation for its antibody candidate GBR 1342 which is under development for the treatment of patients with multiple myeloma who have received prior therapies. The United States Food and Drug Administration (USFDA) has granted orphan drug designation (ODD) to company's bispecific antibody candidate GBR 1342 that is being investigated for the treatment of multiple myeloma, Glenmark said in a statement. The candidate is one of five clinical-stage assets in the pipeline of Glenmark's new innovation company, it added.
"As one of our first important pipeline milestones, we are excited that the FDA has recognised the potential for GBR 1342 to offer a significant advancement for patients with multiple myeloma," Alessandro Riva, MD and CEO of the new company (which is yet to be named) said.
The USFDA grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 2 lakh people in the US, Glenmark said.
The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and, upon regulatory approval, seven years of market exclusivity, it added.
Shares of Glenmark Pharmaceuticals were trading at Rs 374.60 per scrip on BSE, up 0.28 per cent from its previous close.