Rhizen Pharmaceuticals gets USFDA nod for cancer drug Umbralisib
February 09, 2021
In a first, Indian scientists develop oral drug for relapsed or refractory MZL, FL
In a major breakthrough in cancer treatment, Alembic Pharmaceutical’s co-owned Rhizen Pharmaceuticals has received US drug regulator - US Food and Drug Administration (USFDA)’s approval for novel next generation oral inhibitor of phosphoinositide 3 kinase (PI3K) delta - Umbralisib for treatment of relapsed or refractory marginal zone lymphoma (MZL), follicular lymphoma (FL).
Umbralisib will be marketed by Nasdaq-listed TG Therapeutics, which led its clinical development, under the brand name of Ukoniq. Rhizen Pharmaceuticals co-owned by Alembic Pharmaceuticals with 50 per cent% stake and the rest by Dr Swaroop Vakkalanka, who is President & CEO of the company.
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Umbralisib (UKONIQ) granted accelerated approval by US FDA for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL), follicular lymphoma (FL).
Umbralisib, a novel next generation inhibitor of PI3K delta CK1 epsilon, was discovered by Rhizen Pharmaceuticals and subsequently licensed to TG Therapeutics, who led the asset s clinical development.
Rhizen and its affiliate Alembic Pharma to support TG Therapeutics towards UKONIQ s commercialization as its manufacturing supply partner; Rhizen plans to register and commercialize Umbralisib in India.
Rhizen Pharmaceuticals, a clinical-stage oncology-focused biopharmaceutical company, today announced that its novel next generation PI3K-delta inhibitor, Umbralisib, which was licensed to TG Therapeutics (NASDAQ:TGTX), has secured US FDA accelerated approval for the treatment of:
First new chemical entity discovered by Indian scientists gets USFDA approval
Rhizen has retained commercialisation rights for India while also being the manufacturing and supply partner for Umbralisib. Alembic owns 50 per cent stake in Rhizen
PB Jayakumar | February 9, 2021 | Updated 12:10 IST
Umbralisib receives USFDA approval
Umbralisib, a novel cancer drug discovered and out-licensed by India s Alembic Pharmaceuticals and its associate drug discovery company Rhizen Pharmaceuticals, has received the drug regulatory approval for sales in the US market. The drug is touted to be the first new chemical entity (NCE) discovered by Indian scientists to secure a US Food and Drug Administration (FDA) approval.