Takeda Pharma gets CDSCO panel nod to market Vadolizumab for subcutaneous route

Last year, the Medical Dialogues Team had reported that Takeda India, part of the Takeda Pharmaceutical Company Limited, had announced the expansion of its highly innovative portfolio for patients in the country with the launch of Kynteles (generic name: Vedolizumab) as part of its Gastrointestinal (GI) portfolio.

Kynteles is used for the treatment of adult patients with moderate to severely active Ulcerative Colitis (UC) and Crohn's Disease (CD). Vedolizumab is a gut-selective biologic and is approved as an intravenous formulation.

At the recent SEC meeting for Gastroenterology & Hepatology held on 17.12.2021, the committee extensively evaluated the drug maker Takeda Pharmaceuticals' proposal for the import and marketing of additional strength and a new route of administration of Vedolizumab.

The committee noted that Vedolizumab through the IV route is already approved for marketing in the country. Furthermore, the proposed additional strength through the subcutaneous route has been approved in the EU, Switzerland, etc.

After detailed deliberation, the committee recommended the grant of marketing permission for Vedolizumab of additional strength through the subcutaneous route. Further, the committee directed that the indication should reflect that the additional strength is for the subcutaneous route and only for maintenance purposes.