In a regulatory filing, Alembic Pharma said Rhizen Pharmaceuticals’ Umbralisib, which was licensed to TG Therapeutics has secured the United States Food and Drug Administration (USFDA) accelerated approval for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) and Follicular Lymphoma (FL).
Umbralisib was earlier granted breakthrough therapy designation (BTD) for the treatment of MZL and orphan drug designation (ODD) for the treatment of MZL and FL, the company added.
In 2014, Rhizen Pharma and TG Therapeutics entered into a licensing agreement as a part of which TG Therapeutics obtained worldwide rights and Rhizen has retained commercialisation rights for India while also being the manufacturing and supply partner for Umbralisib.
Swaroop Vakkalanka, President and CEO of Rhizen Pharmaceuticals said, “Umbralisib’s approval offers MZL and FL patients a new treatment option and is a huge validation of Rhizen’s drug discovery and development capabilities. We are keen to bring Umbralisib to Indian patients and we plan to initiate activities towards registration and approval there soon.” Shares of Alembic Pharma were trading 0.47 per cent higher at Rs 946 apiece on BSE.