Lilly's Oral JAK1/2 Inhibitor Olumiant (Baricitinib) Faces U.S. Regulatory Delay for New Indication in Moderate-to-Severe Atopic Dermatitis
Jul 18, 2021 01:55
CST Updated
01:55
Eli Lilly
Global Pharmaceutical R&D and Production Company
Atopic Dermatitis (Image source: icresearch.net)
July 17, 2021 /BioonBIOON/ -- Eli Lilly and its partner Incyte recently announced that the U.S. Food and Drug Administration (FDA) will not, on the Prescription Drug User Fee Act (PDUFA) target action date,Oral JAK inhibitor Olumiant (Chinese brand name: Aileming, generic name: baricitinib)made a review decision on the supplemental new drug application (sNDA). This sNDA seeks approval for a new indication for Olumiant:For the treatment of adult patients with moderate-to-severe atopic dermatitis (AD)。Eli Lillystates,FDAThis action does not affect the company's previously issued financial guidance for 2021.
This delay is related to the FDA's ongoing review of JAK inhibitors. JAK inhibitors represent a promising class of novel therapies for the treatment of various autoimmune diseases; however, this class of drugs has faced scrutiny due to safety concerns.
The active pharmaceutical ingredient of Olumiant is baricitinib, which is an oral JAK1/JAK2 inhibitor discovered by Incyte, byEli LillyDeveloped under license from Incyte. In November 2020, Olumiant was approved in the EU for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. Notably,Olumiant is the world's first JAK inhibitor approved for the treatment of atopic dermatitis (AD).On the US side, in early April this year,FDAThe review period for Olumiant's indication for the treatment of AD has been extended by three months to early Q3 2021.
Eli LillyIlya Yuffa, Senior Vice President and President of Eli Lilly and Company, stated: "We are confident in the efficacy and safety of Olumiant for the treatment of atopic dermatitis, and look forward to continuing to work withFDACollaboration. We are committed to bringing Olumiant to market to help meet the needs of patients with atopic dermatitis.”
Atopic dermatitis (AD) is a severe chronic inflammatory skin disease primarily characterized by intense pruritus, prominent eczematous changes, and dry skin. It typically begins in infancy or early childhood and may persist throughout life in some patients. The condition can severely impair patients' quality of life due to chronic recurrent eczematous rashes, severe pruritus, sleep loss, dietary restrictions, and psychosocial impacts.
The active pharmaceutical ingredient of Olumiant is baricitinib, a selective, reversible JAK1 and JAK2 inhibitor currently in clinical development for various inflammatory diseases andAutoimmunitytreatment of immune-mediated diseases, including rheumatoid arthritis (RA), psoriasis,Diabetes mellitusRenal disease, atopic dermatitis (AD), systemic# Lupus Erythematosus(SLE), juvenile idiopathic arthritis (JIA), etc. There are four types of JAK enzymes: JAK1, JAK2, JAK3, and TYK2. JAK-dependent cytokines are involved in various inflammatory and`Autoimmunity`The pathogenesis of these diseases suggests that JAK inhibitors may be widely used for the treatment of various inflammatory diseases. In kinase assays, baricitinib demonstrated an inhibitory potency against JAK1 and JAK2 that was 100-fold greater than that against JAK3.
To date, Olumiant has been approved and marketed in over 75 countries (including the United States, China, the European Union, and Japan) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). Additionally, Olumiant has been approved in more than 40 countries (including the entire European Union and Japan) for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD). Recently, Olumiant has also been approved in Japan for the treatment of COVID-19-associated pneumonia in hospitalized adult patients.
In the treatment of RA,The approved doses of Olumiant are 4 mg and 2 mg in the European Union, 2 mg in the United States, and 2 mg in China.Regarding administration, Olumiant is administered orally once daily and may be used 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 U.S. prescribing information for Olumiant carries a boxed warning regarding serious infections, malignancies,Tumorand the risk of thrombosis. (Bioon.com)