Rhizen receives US FDA orphan drug designation

The US Food and Drug Administration (US FDA) has granted orphan drug designation for Tenalisib (RP6530) for the treatment of patients with peripheral T-cell lymphoma (PTCL), Alembic Pharmaceuticals said in a BSE filing.

The US FDA grants orphan drug designation to a drug or biological product intended to treat a rare disease in the US. "A number of incentives are provided for an orphan-drug such as seven-year marketing exclusivity, tax credits for clinical development costs, exemption/waiver of application fees and assistance from FDA Office of Orphan Products Development (OOPD) during the process," the company added.

Earlier this month, the US FDA had granted fast track designation to Rhizen Pharmaceuticals’ RP6530. Fast track designation is awarded to drugs that treat a serious condition and fill an unmet medical need.