Eli Lilly Provides Update on U.S. sNDA Status for Olumiant (baricitinib) in Moderate-to-Severe Atopic Dermatitis

News on January 28, 2022 /BioValleyBIOON/ --Eli Lilly(Eli Lilly) and its partner Incyte recently announcedOral JAK Inhibitor Olumiant (Chinese Brand Name: 艾乐明, Generic Name: Baricitinib) U.S. Atopic Dermatitis (AD)Update on the Status of the Supplemental New Drug Application (sNDA).

Eli LillyIn discussions with the U.S. Food and Drug Administration (FDA) discussed the sNDA status of Olumiant for the treatment of adult patients with moderate to severe AD. At this point,The company has no connection with the United States.FDAReach a consensus on the applicable population.

In view of the position of this organization, it is possible that a Complete Response Letter (CRL) may be issued. Among the 8 items of ADClinical TrialThe efficacy and safety of Olumiant were evaluated in (6 double-blind, randomized, placebo-controlled studies and 2 long-term extension studies), which included patients whose conditions were not adequately controlled by topical prescription therapies or for whom these therapies were not desirable. The safety profile in these trials was consistent with previously published Olumiant data.

The active pharmaceutical ingredient in Olumiant is baricitinib, an oral JAK1/JAK2 inhibitor discovered by Incyte andEli LillyDeveloped under license from Incyte. Regulatory aspects,Olumiant is the first JAK inhibitor approved in the EU and Japan for the treatment of moderate to severe atopic dermatitis (AD) patients who have an inadequate response to topical therapies.

Atopic Dermatitis (AD) is a severe chronic inflammatory skin disease, primarily characterized by intense itching, significant eczematous changes, and dry skin. The condition often begins in infancy or early childhood, with some patients experiencing lifelong persistence. It can severely impact the patient's quality of life due to chronic recurrent eczematous rashes, severe itching, sleep deprivation, dietary restrictions, and psychosocial effects.

Olumiant's active pharmaceutical ingredient is baricitinib, a selective and reversible JAK1 and JAK2 inhibitor currently in clinical development for various inflammatory diseases andAutoimmuneTreatment of autoimmune diseases, including rheumatoid arthritis (RA), psoriasis,DiabetesKidney disease, Atopic Dermatitis (AD), SystemicSystemic Lupus Erythematosus(SLE), Juvenile Idiopathic Arthritis (JIA), etc. There are four types of JAK enzymes, namely JAK1, JAK2, JAK3, and TYK2. JAK-dependent cytokines are involved in various inflammatory processes andAutoimmunityThe pathogenesis of sexually transmitted diseases suggests that JAK inhibitors may be widely used to treat various inflammatory diseases. In kinase assays, baricitinib demonstrated 100 times greater inhibitory potency against JAK1 and JAK2 than against JAK3.

To date, Olumiant has been approved and launched in more than 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 is approved in over 40 countries (including the entire European Union and Japan) for the treatment of adult patients with moderate to severe atopic dermatitis (AD). Furthermore, Olumiant is also approved in Japan for the treatment of hospitalized adult patients with pneumonia associated with COVID-19.

In the treatment of RA, the approved doses of Olumiant are 4mg and 2mg in the EU, 2mg in the US, and 2mg in China. Olumiant is taken orally once daily, either as monotherapy or in combination with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs (non-biologic DMARDs). It is not recommended to use Olumiant in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants such as azathioprine and cyclosporine. Notably, the US label for Olumiant includes a black box warning regarding the risks of serious infections and malignancies.TumorAnd the risk of thrombosis. (Bioon.com)

Source of Original Text:Updates on OLUMIANT® (baricitinib) Phase 3 lupus program and FDA review for atopic dermatitis