EMA Panel Backs Baricitinib for Moderate-to-Severe Atopic Dermatitis

Megan Brooks

September 22, 2020

The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of baricitinib tablets (Olumiant, Eli Lilly) for adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.

Baricitinib is already approved in the European Union (EU; and the United States) to treat moderate-to-severe active rheumatoid arthritis.

If approved in Europe, it will be the first Janus kinase (JAK) inhibitor and first oral medication indicated to treat patients with AD.

The CHMP's positive opinion on baricitinib for AD was based on three phase 3 randomized, double-blind, placebo-controlled studies where the JAK inhibitor was used alone or in combination with topical treatments in adults with moderate-to-severe AD for whom topical treatments were insufficient or not tolerated.

In all three studies, baricitinib was shown to be more effective than placebo in achieving skin that is "clear" or "almost clear" at 16 weeks.

"Patients living with AD face difficulties on a daily basis, and this CHMP opinion marks an important milestone in providing adult AD patients with a new potential treatment option," Thomas Bieber, MD, PhD, professor of dermatology and allergy, University of Bonn, Germany, said in a company news release.

The most common side effects with baricitinib in clinical trials include increased LDL cholesterol, upper respiratory tract infections, and headache.

Patients receiving baricitinib, particularly in combination with immunosuppressants, are at risk of developing serious infections that may lead to hospitalization or death. If a serious infection develops, baricitinib should be stopped until the infection is controlled.

The CHMP's positive opinion will be sent to the European Commission, which will adopt a final decision regarding an EU-wide marketing authorization. Once granted, each member state will make decisions about price and reimbursement, taking into account the potential role/use of baricitinib in the context of that country's national health system.

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