Lyka Labs Gets CDSCO Panel Nod To Manufacture, Market Atopic Dermatitis Drug
New Delhi: Lyka Lab has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the Tofacitinib Ointment 2% w/w for the treatment of mild to moderate atopic dermatitis (AD) in patients 18 years and above having a flare-up of disease with subject to the condition that the firm should conduct Phase-IV clinical trial study.
This came after the firm presented clarifications and corrective action plans against observations noted during the clinical trial (CT) inspection conducted on 18.07.2023 on their randomly selected two clinical trial sites for verification of raw data before the committee.
Atopic dermatitis, often referred to as eczema, is a chronic (long-lasting) disease that causes inflammation, redness, and irritation of the skin.
Tofacitinib is an inhibitor of Janus kinases, a group of intracellular enzymes involved in signaling pathways that affect hematopoiesis and immune cell function. It is used to treat rheumatic conditions, such as rheumatoid arthritis, ankylosing spondylitis, and ulcerative colitis.
At the recent SEC meeting for dermatology and allergy held on 13th August 2023, the expert panel reviewed the clarification and corrective action plans presented by Lyka Lab against observations noted during the CT inspection conducted on 18.07.2023 on their randomly selected two clinical trial sites for verification of raw data before the committee.
In the above meeting, the committee noted that the observations raised during the inspection do not attribute to the quality of the product and there is no such observation that raises the question with respect to authenticity of data.
After detailed deliberation, the committee recommended the grant of permission for manufacturing and marketing of Tofacitinib Ointment 2% w/w for the treatment of mild to moderate atopic dermatitis (AD) in patients 18 years & above having a flare-up of disease subject to the condition that the firm should conduct Phase-IV clinical trial study.
In addition to the above, the expert panel stated that the firm should also fulfill the CMC (Chemistry, Manufacturing, and Controls) data requirement as per the New Drugs and Clinical Trials Rules, 2019.
Accordingly, the expert panel suggested that the firm should submit the Phase-IV clinical trial protocol to CDSCO within 03 months from the date of approval of the drug product for further review by the committee.
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