CDSCO Panel Accepts Glenmark's Apremilast Trial Report, Seeks 2-Year PSUR Data
Glenmark
New Delhi: Glenmark Pharmaceuticals Limited has received approval from the Subject Expert Committee (SEC), functioning under the Central Drugs Standard Control Organisation (CDSCO), for its Phase-IV clinical trial study report on Apremilast 10/20/30 mg tablets for the treatment of active psoriatic arthritis, subject to submission of ongoing post-marketing safety data.
The matter was discussed at the 7th meeting of the SEC held on 23rd July 2025 at CDSCO headquarters, New Delhi. Referring to its earlier recommendation dated 14th March 2024, the committee reviewed Glenmark’s summary report, which included data from 169 patients, along with justification for closure of the study, real-world clinical data, and Periodic Safety Update Reports (PSURs).
Apremilast is an oral phosphodiesterase 4 (PDE4) inhibitor approved for treating moderate to severe plaque psoriasis and active psoriatic arthritis. It has gained traction in India due to supportive global and Indian studies demonstrating long-term safety and efficacy in autoimmune dermatological conditions.
After reviewing the clinical trial outcomes and safety profile, the expert panel found the data relevant for therapeutic application in the Indian population.
“After detailed deliberation, the committee recommended to accept the Phase-IV clinical trial study report with 169 patients data subject to condition that further periodic safety update reports (PSUR) data for two more years to be submitted by the firm for active psoriatic arthritis,” the committee noted.
