MSN Labs gets CDSCO panel nod to manufacture, market Tofacitnib Oral Solution
New Delhi: Granting waivers for local clinical trials and bioavailability/bioequivalence (BA/BE) studies, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has given its nod to MSN Laboratories to manufacture and market the Tofacitinib Oral solution 1mg/ml for the treatment of juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older.
However, this approval is subject to the condition that the firm should conduct the Phase IV clinical trial.
This came after the drug major MSN Laboratories presented the proposal for a grant of permission for manufacturing and marketing of Tofacitinib Oral solution 1mg/ml for the treatment of juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older along with the results of a clinical trial conducted in Indian and Asian patients by innovator and summary on safety data in paediatrics patients with a request for local clinical trial and BA/BE study wavier.
Juvenile idiopathic arthritis, formerly known as juvenile rheumatoid arthritis, is the most common type of arthritis in children under the age of 16.
Juvenile idiopathic arthritis can cause persistent joint pain, swelling and stiffness. Some children may experience symptoms for only a few months, while others have symptoms for many years. Some types of juvenile idiopathic arthritis can cause serious complications, such as growth problems, joint damage and eye inflammation.
Tofacitinib is in a class of medications called Janus kinase (JAK) inhibitors. It works by decreasing the activity of the immune system. Tofacitinib inhibits the process of intracellular signalling from the receptor to the cellular nucleus and inhibits the inflammation process via a new pathway (inhibition of the Janus kinases), which is unavailable to biological medicines.
Tofacitinib is used alone or with other medications to treat rheumatoid arthritis in adults who are unable to take or did not respond to one or more tumour necrosis factor (TNF) inhibitor medication(s).
At the recent SEC meeting for Analgesic and Rheumatology held on 7th June 2023, the expert panel reviewed the proposal presented by MSN Laboratories for the grant of permission for manufacturing and marketing Tofacitinib Oral solution 1mg/ml for the treatment of juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older.
The committee noted that the Tofacitinib Oral solution 1mg/ml was already approved in the USA on 06th Nov 2012, in Europe on 22nd Mar 2017, for the treatment of juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older.
After detailed deliberation, the committee recommended the grant of permission for manufacturing and marketing of the drug in the country subject to the condition that the firm should conduct a Phase IV clinical trial.
Accordingly, the xpert panel suggested that the firm should submit the Phase IV clinical trial protocol within 3 months from the date of approval of the drug for further review by the committee
