Eli Lilly Gets CDSCO Panel Nod for Ixekizumab Safety Label Update
New Delhi: Eli Lilly and Company (India) Pvt Ltd has secured regulatory clearance from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) for updating the package insert of its drug Ixekizumab Solution for Injection 80 mg/mL, in both pre-filled autoinjector and pre-filled syringe formats.
The approval pertains to Package Insert Version 2 dated November 2024, incorporating changes in the sections of Special Warnings and Precautions for Use, Undesirable Effects, Post-Marketing Experience, and Patient Counselling Information. These updates are aligned with the USFDA package insert update approval dated 20th August 2024.
The matter was reviewed during the SEC (Dermatology & Allergy) meeting held on 23rd July 2025 at CDSCO headquarters, New Delhi. After detailed deliberation, the committee “recommended for approval of updated package insert Version 2 dated November 2024 of the said drug product for the proposed changes.”
Ixekizumab, a monoclonal antibody, works by selectively binding to interleukin-17A (IL-17A), a pro-inflammatory cytokine involved in the pathogenesis of psoriasis and psoriatic arthritis. The drug is indicated for the treatment of moderate-to-severe plaque psoriasis in patients who may benefit from phototherapy or systemic therapy, and for active psoriatic arthritis, either alone or in combination with other disease-modifying agents such as methotrexate.
