The first JAK inhibitor to treat adiotic dermatitis (AD)! Lilly Olumiant's new adaptation is recommended for approval by THECHMP!

September 20, 2020 // -- Eli Lilly and partner Incyte recently announced that the European Medicines Agency (EMA) Committee on Human Pharmaceutical Products (CHMP) has issued an active review recommending approval of oral JAK inhibitor Olumiant (baricitinib) for the treatment of moderate to severe endexual dermatitis (AD) patients suitable for systematic treatment.
chMP's comments will now be submitted to the European Commission for review, which is expected to make a final review decision in the next 1-2 months.
note that the positive comments from CHMP represent Olumiant's first regulatory action in the treatment of AD.
approved, Olumiant would be the first JAK inhibitor to treat AD.
Jonsson, Senior Vice President and President of Lilly Biopharmaceuticals, said, "With limited treatment options currently available to adult AD patients, we are pleased to further explore the potential benefits of Olumiant for AD patients.
at Lilly, we are eager to raise the standard of treatment for people with skin diseases.
chMP opinion brings us closer to bringing a new drug to adults with AD in Europe.
"CHMP's positive comments, based on data from the Phase 3 BREEZE-AD Clinical Development Program of Olumiant Therapeutic AD, including: (1) 2 single-drug studies of BREEZE-AD1 and BREEZE-AD2 in Olumiant's treatment of moderate to severe AD patients; A joint study of BREEZE-AD4 in patients with moderate to severe AD who were not effective, insatiable, or had contraindications in the treatment of local corticosteroids in the treatment of local corticosteroids;
all studies reached the primary endpoint: Olumiant significantly improved the severity of the disease and a higher percentage of patient skin loss was completely removed when treated with monotherapy and combined standards for local corticosteroids compared to placebos.
(AD) is a serious chronic inflammatory skin disease, mainly manifested in severe itching, obvious eczema-like changes and dry skin.
the disease is often self-admission, some patients continue for life, can be due to chronic relapsed eczema-like rash, severe itching, sleep deprivation, dietary restrictions and psychosocial effects and seriously affect the quality of life of patients.
Olumiant's active pharmaceutical ingredient is baricitinib, a daily oral selective, reversible JAK1 and JAK2 inhibitors that is currently under clinical development for the treatment of a variety of inflammatory and autoimmune diseases, including rheumatoid arthritis (RA), psoriasis, diabetic nephropathy, endexual dermatitis, systemic lupus erythematosus, etc.
there are four types of JAK enzymes, JAK1, JAK2, JAK3 and TYK2.
involve JAK-dependent cytokines in the onset of a variety of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be widely used to treat a variety of inflammatory diseases.
in kinase tests, baricitinib showed 100 times more inhibition for JAK1 and JAK2 than JAK3.
Lilly and Incyte reached an exclusive cooperation agreement in 2009 to jointly develop Olumiant and a number of subsequent compounds.
To date, Olumiant has been approved by more than 60 countries around the world, including the United States, the European Union, and Japan, as a single drug or combination methotrexate for the treatment of adult patients with moderate to severe active rheumatoid arthritis (RA) who are undertreated or insulated with one or more disease-modified rheumatoid drugs (DMARD).
in clinical studies, Oluminant significantly improved RA symptoms and signs compared to standard care therapies such as methotrexate monotherapy, Adamo monotherapy, and Adamo monoantigen background methotrexate therapy.
4mg and 2mg in the EU and 2mg in the US.
,Olumiant,(MTX)(non-biologic DMARDs)。
is not recommended to use Olumiant in combination with other JAK inhibitors, or biological DMARD, powerful immunosuppressants such as thiopental and cyclosporine.
note that Olumiant's U.S. drug label has a black-box warning about the risk of serious infection, malignant tumors and thrombosis.
() Original origin: CHMP Recommends approval of Lilly's Baricitinib for The Treatment of Adults with Moderate to Severe Atopic Dermatitis.