Submit Safety Data with Subgroup Analysis of CT: CDSCO Panel Tells Akum Pharma on Tofacitinib Oral Solution

Written by Dr. Divya Colin Published On 2022-11-26T17:45:56+05:30 | Updated On 26 Nov 2022 5:45 PM IST

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.

This came after the firm presented the proposal for manufacturing and marketing of Tofacitinib Oral Solution 1mg/ml for the indication for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older who have had an inadequate response or indolence to one or more TNF blockers.

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.

Tofacitinib is indicated for treating adult patients with moderately-to-severely active rheumatoid arthritis (RA), active psoriatic arthritis, active ankylosing spondylitis, or moderately-to-severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers.

Tofacitinib inhibits intracellular signalling from the receptor to the cellular nucleus. It inhibits the inflammation process via a new pathway (inhibition of the Janus kinases), which is unavailable to biological medicines.

At the recent SEC meeting for Analgesic & Rheumatology held on November 16 2022, the expert panel reviewed the proposal to manufacture and market the Tofacitinib Oral Solution 1mg/ml for the indication for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older who have had an inadequate response or indolence to one or more TNF blockers.

After detailed deliberation, the committee recommended that the firm should submit safety data/PMS 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. The proposal may be redeliberated in the presence of a paediatrician.

Also Read:CDSCO panel approves GSK pharma's protocol amendment proposal for Mepolizumab Powder for Solution for Injection

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Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.