Last Updated on December 31, 2023 by The Health Master
New Delhi: Takeda Pharmaceuticals has got the go ahead from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) for marketing the gastrointestinal drug, Vedolizumab with additional strength thru the subcutaneous route.
This came in line with the proposal presented by Takeda Pharmaceuticals for the import and marketing of additional strength and a new route of administration of Vedolizumab.
Vedolizumab is a recombinant humanized IgG1 monoclonal antibody directed against the human lymphocyte α4β7 integrin, a key mediator of gastrointestinal inflammation.
It is used in the treatment of moderate to severe active ulcerative colitis and Crohn’s disease for patients who have had an inadequate response to, lost response to, or are intolerant to inhibitors of tumor necrosis factor-alpha (TNF-alpha) or other conventional therapies. By blocking its primary target, α4β7 integrin, vedolizumab reduces inflammation in the gut.
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 thru 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.
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