Submit Safety Data with Subgroup Analysis of CT: CDSCO Panel Tells Akum Pharma on Tofacitinib Oral Solution
New Delhi: Regarding the proposal for manufacturing and marketing of anti-rheumatic drug Tofacitinib Oral Solution 1mg/ml, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended the drug major Akum Pharmaceutical to submit safety data/PMS (Postmarketing surveillance) data in pediatric patients (2-17 years) along with subgroup analysis of clinical trials conducted by innovators in Indian and Asian patients for further review by the committee.
Polyarticular juvenile idiopathic arthritis (formerly called polyarticular-onset juvenile rheumatoid arthritis [RA]) is a subset of juvenile idiopathic arthritis (JIA) that is defined by the presence of more than four affected joints during the first six months of illness. Polyarticular JIA is an autoimmune disease. This means that the body's immune system, which normally attacks germs, mistakenly attacks the joints. This causes inflammation (swelling and irritation) in the joints and other problems. Polyarticular JIA usually starts when kids are 1–3 years old, or 10–14 years old.
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