Eli Lilly and Company (India) Pvt Ltd has recently obtained regulatory clearance from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) to revise the package insert for its drug Ixekizumab Solution for Injection 80 mg/mL, available in pre-filled autoinjector and pre-filled syringe formats.
The approval revolves around the Package Insert Version 2 dated November 2024, encompassing modifications in various sections like Special Warnings and Precautions for Use, Undesirable Effects, Post-Marketing Experience, and Patient Counselling Information. These adjustments mirror the updates authorized by the USFDA package insert revision granted on 20th August 2024.
A crucial discussion on this matter took place during the SEC (Dermatology & Allergy) meeting on 23rd July 2025 at the CDSCO headquarters in New Delhi. Following a meticulous evaluation, the committee endorsed the revised package insert Version 2 of the drug product dated November 2024, endorsing the proposed changes.
Ixekizumab, classified as a monoclonal antibody, operates by specifically binding to interleukin-17A (IL-17A), a pro-inflammatory cytokine implicated in the development of psoriasis and psoriatic arthritis. The drug is prescribed for patients with moderate-to-severe plaque psoriasis who may benefit from phototherapy or systemic therapy, as well as those with active psoriatic arthritis, either as a standalone treatment or in conjunction with other disease-modifying agents like methotrexate.
Key Takeaways:
– Eli Lilly has secured approval for updating the safety label of Ixekizumab Solution for Injection from the CDSCO SEC.
– The revisions in the package insert align with the USFDA update approval granted in August 2024.
– Ixekizumab’s mechanism involves targeting interleukin-17A, essential in the pathogenesis of psoriasis and psoriatic arthritis.
– The drug is indicated for moderate-to-severe plaque psoriasis and active psoriatic arthritis, offering various treatment options.
Tags: regulatory
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