Intas secures CDSCO panel nod to study arthritis drug Adalimumab
New Delhi: In a significant development, drug firm Intas has got a green signal from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) to conduct a study of rheumatoid arthritis drug Adalimumab.
This nod, however, is conditional on a number of factors. The expert panel has instructed the firm that the Principal Investigator of the study should be a Rheumatologist or a MD in Medicine with experience in Rheumatology.
Furthermore, the committee recommended that half of the clinical trial sites be from government hospitals and institutions.
This came in the wake of the proposal presented by Intas to conduct a Phase III Clinical Trial (Protocol No. 0881-19, Version: 1.2) of Adalimumab.
Adalimumab is a monoclonal anti-tumor necrosis factor alpha antibody used in the treatment of a wide variety of inflammatory conditions such as rheumatoid arthritis, Crohn's disease, and ankylosing spondylitis.
The said drug was originally launched by Abbvie in the U.S. and approved in 2002 by the FDA. Adalimumab is popular under the brand name Humira by Abbvie.
Last year, Medical Dialogues Team had reported that Cadila Pharmaceuticals had launched Adalimumab biosimilar under the brand name Cadalimab for the domestic market.
Cadalimab is available in a 40mg/0.8ml injection and the medication has been found to significantly reduce the signs and symptoms of Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, and Psoriasis.
Tumor Necrosis Factor-alpha (TNF-alpha) is a naturally occurring cytokine that plays a role in normal inflammatory and immune responses . Increased levels of TNF are found in the joint synovial fluid of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis patients, and play an imperative role in pathologic inflammation and the joint destruction that are major complications of these diseases.
Adalimumab acts by binding with specificity to tumor necrosis factor-alpha (TNF-alpha) and inhibits its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also lyses surface tumor necrosis factor expressing cells in vitro when in the presence of complement.
At the recent SEC meeting for analgesics and rheumatology, the committee thoroughly reviewed the proposal presented by Intas for conducting a Phase III Clinical Trial (Protocol No. 0881-19, Version: 1.2) of Adalimumab.
After detailed deliberation, the committee recommended the grant of permission for the conduct of the study, subject to the following conditions:
1. The firm should clarify the colour of the product.
2. The Principal Investigator should be a Rheumatologist or a MD in Medicine with experience in Rheumatology.
3. 50% of clinical trial sites from government hospitals and institutions should be included in the study.
