Exclude patients with history of TB from Baricitinib clinical study for Atopic Dermatitis: CDSCO panel tells Eli Lilly
New Delhi: The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has asked Eli Lilly to conduct a clinical study of Baricitinib for Atopic Dermatitis on a clinically significant number of patients by excluding patients with past history or with concurrent TB.
This came after the drug maker presented the proposal for import and marketing of Baricitinib Tablets 2mg and 4mg indicated for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy (additional indication), requesting a clinical trial waiver.
Atopic Dermatitis (AD), also known as atopic eczema, is a kind of dermatitis (skin inflammation) that causes itchy, red, swollen, and cracked skin. The term eczema is broadly applied to a range of persistent skin problems whose symptoms include dryness and skin rashes that are characterized by one or more symptoms like scratching, redness, and flaky skin.
Baricitinib is an orally administered small molecule Janus kinase inhibitor used to treat moderate-to-severe rheumatoid arthritis. It received emergency use authorisation in late 2020 for severe COVID-19 in combination with Remdesivir.
Recently, the SEC committee, in its 57th meeting (Dermatology & Allergy) held on 09.06.2021 at CDSCO, reviewed the proposal presented by Eli Lilly.
Responding to the proposals, after detailed deliberation, the committee recommended that the firm should conduct a clinical study on a clinically significant number of patients by excluding patients with a past history or with concurrent TB.
In addition, the committee recommended that photographs should be captured during the conduct of studies.
Accordingly, the firm should submit the Phase III clinical trial protocol to CDSCO for review by the committee.
Baricitinib is already approved in more than 70 countries as a treatment for adults with moderately to severely active rheumatoid arthritis (RA).