CDSCO Panel Approves Johnson and Johnson's Protocol Amendment Proposal to Study JNJ-77242113

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-07-19T17:45:38+05:30 | Updated On 19 July 2024 5:45 PM IST

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Johnson and Johnson's protocol amendment proposal for the drug JNJ-77242113.

This came after the firm presented Protocol Amendment 3 dated 02 April 2024 protocol no. 7242113UCO2001.

JNJ-77242113 or JNJ-2113 stands out as the first oral peptide specifically designed to inhibit the IL-23 receptor. This means it blocks the activity of the IL-23 receptor, which is a protein involved in the immune system's inflammatory processes. Interleukin-23 plays a significant role in the development and progression of plaque psoriasis, a chronic skin condition characterized by red, itchy, and scaly patches. By inhibiting the IL-23 receptor, JNJ-2113 can potentially reduce the inflammation, proliferation, and development of psoriatic plaques, thereby alleviating symptoms associated with moderate-to-severe plaque psoriasis.

The mechanism of action of JNJ-2113, a targeted oral peptide, involves specifically blocking the activity of the interleukin-23 (IL-23) receptor, which plays a critical role in the immune system's inflammatory processes.

At the recent SEC meeting for gastroenterology and hepatology held on June 20, 2024, the expert panel reviewed Protocol Amendment 3 dated 02 April 2024 protocol no. 7242113UCO2001.

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

Also Read: Cipla Gets CDSCO Panel Nod to Study Plazomicin Injection

JNJ-77242113cdscoJohnson & Johnsonprotocol amendment

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.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751