Wednesday, August 14, 2013

The NDAC ( Analgesics, Anesthetics & Rheumatology) recommends against approval for Pfizer's Tofacitinib in India - Demands Additional trial

Pfizer presented the global clinical trial data on its novel JAK inhibitor - Tofacitinib including the clinical trial data generated on 120 Indian subjects for the purpose of an approval in India to the NDAC (Analgesics, Anesthetics & Rheumatology). 

The NDAC recommended against approval as it noted that the number of of patients enrolled in the Indian study is  not statistically significant for recommending Marketing Authorisation. Hence the committee recommended for conducting a trial on statistically significant no. of Indian subject.   The committee recommended that sites should be Multispecialty hospitals/institutes having own Institutional Ethics Committee including 50% of sites being government hospitals across the country. Accordingly CT protocol etc., may submitted to DCG(I) for further review of the committee.

Tofacitinib has been approved for use by the USFDA, while the European regulators have recommended against an approval. 


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