Lilly's Olumiant Becomes First JAK Inhibitor Approved in EU for Moderate-to-Severe Atopic Dermatitis

November 05, 2020 /BioValleyBIOON/ --Eli Lilly(Eli Lilly) and partner Incyte recently announced that the European Commission (EC) has approved a new indication for the oral JAK inhibitor Olumiant (baricitinib): for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.

The active pharmaceutical ingredient of Olumiant is baricitinib, an oral JAK1/JAK2 inhibitor discovered by Incyte,Eli LillyDeveloped under license from Incyte.

It is particularly worth mentioning that,Olumiant is the first JAK inhibitor approved by regulatory authorities for the treatment of AD, and also the first oral medication for the treatment of AD.

The approval of this new indication is based on data from the Phase 3 BREEZE-AD clinical development program for Olumiant in the treatment of AD, including: (1) two monotherapy studies, BREEZE-AD1 and BREEZE-AD2, evaluating Olumiant in patients with moderate-to-severe AD; (2) the combination study BREEZE-AD4, assessing Olumiant plus topical corticosteroids in patients with moderate-to-severe AD who were inadequate responders to, intolerant of, or had contraindications to cyclosporine; and (3) the combination study BREEZE-AD7, evaluating Olumiant plus topical corticosteroids in patients with moderate-to-severe AD.

All studies met the primary endpoint: Olumiant significantly improved disease severity and resulted in a higher proportion of patients achieving complete skin clearance compared with placebo, both as monotherapy and in combination with standard-of-care topical corticosteroids.

Atopic Dermatitis (AD) is a severe chronic inflammatory skin disease, primarily characterized by intense pruritus, significant eczematous changes, and dry skin. The disease often onset in infancy and childhood, with some patients affected throughout their lifetime. It can severely impair patients' quality of life due to chronic recurrent eczematous rashes, severe pruritus, sleep deprivation, dietary restrictions, and psychosocial impacts.

The active pharmaceutical ingredient of Olumiant is baricitinib, a selective, reversible JAK1 and JAK2 inhibitor administered orally once daily, currently in clinical development for various inflammatory diseases andAutoimmunityTreatment of sexually transmitted diseases, including classRheumatoid Arthritis(Rheumatoid Arthritis), Psoriasis,DiabetesRenal Disease, Atopic Dermatitis, SystemicLupus Erythematosusetc. There are four JAK enzymes: JAK1, JAK2, JAK3, and TYK2. JAK-dependent cytokines are involved in various inflammatory andAutoimmunityThe pathogenesis of immune-mediated diseases suggests that JAK inhibitors may be widely used for the treatment of various inflammatory disorders. In kinase inhibition assays, baricitinib demonstrated 100-fold greater inhibitory potency against JAK1 and JAK2 than against JAK3.

Eli LillyReached an exclusive collaboration agreement with Incyte in 2009 to jointly develop Olumiant and certain follow-on compounds. To date, Olumiant has been approved in more than 60 countries worldwide (including the United States, the European Union, and Japan) as monotherapy or in combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis in patients who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).Rheumatoid Arthritis(RA) Treatment of adult patients. In clinical studies, Oluminant achieved significant improvement in the signs and symptoms of RA compared with standard-of-care therapies (e.g., methotrexate monotherapy, adalimumab in combination with background methotrexate therapy).

For the treatment of rheumatoid arthritis (RA), Olumiant is approved at doses of 4 mg and 2 mg in the European Union, and at a dose of 2 mg in the United States. Olumiant is administered orally once daily, either as monotherapy or in combination with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs (non-biologic DMARDs). Concomitant use of Olumiant with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (such as azathioprine and cyclosporine) is not recommended. Notably, the US prescribing information for Olumiant includes a boxed warning regarding serious infections and malignancies.Tumorand the risk of thrombosis. (Bioon.com)

Original source: baricitinib receivedapproval in the European Union for the treatment of adult patients with moderate to severe AD