Date: 2017-04-14

Type of information: Refusal of a Market Autorisation in the US

Product name: Olumiant®

Compound: baricitinib (LY3009104)

Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases

Action mechanism: kinase inhibitor/tyrosine kinase inhibitor/janus kinase inhibitor.Baricitinib is a once daily, oral, selective JAK1 and JAK2 inhibitor. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions. Baricitinib demonstrates approximately 100-fold greater potency of inhibition against JAK1 and JAK2 than JAK 3 in kinase assays. In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases. Baricitinib is currently in Phase 3 clinical development for rheumatoid arthritis and Phase 2 development for psoriasis and diabetic nephropathy. Lilly and Incyte conducted four pivotal Phase 3 clinical trials of baricitinib in patients with moderately-to-severely active rheumatoid arthritis to support regulatory submission in most countries. An additional Phase 3 study was initiated to support clinical development in China. The clinical trial program includes a wide range of patients including those who are methotrexate naïve, inadequate responders to methotrexate, inadequate responders to conventional disease-modifying anti-rheumatic drugs, or inadequate responders to TNF inhibitors. Patients completing any of the five Phase 3 studies can enroll in a long-term extension study.

Company: Eli Lilly (USA -IN) Incyte Corporation (USA - DE)

Disease: rheumatoid arthritis

Latest news: • On April 14, 2017, Eli Lilly and Incyte  announced that the FDA has issued a complete response letter for the New Drug Application (NDA) of baricitinib, a once-daily oral medication for the treatment of moderate-to-severe rheumatoid arthritis. The FDA indicated that additional clinical data are needed to determine the most appropriate doses. The FDA also stated that additional data are necessary to further characterize safety concerns across treatment arms. The companies disagree with the Agency's conclusions. The timing of a resubmission will be based on further discussions with the FDA. Lilly and Incyte submitted the NDA for baricitinib to the FDA in January 2016, and in January 2017 announced the FDA's three-month extension to allow time for review of additional data analyses. • On December 16, 2016, Eli Lilly  and Incyte announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending the approval of baricitinib - which if approved would be marketed as Olumiant®. Baricitinib would be indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Baricitinib may be used as monotherapy or in combination with methotrexate. The CHMP positive opinion was based on five phase 3 clinical trials of baricitinib in adult patients with moderate to severe active rheumatoid arthritis (RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON and RA-BEYOND). A wide range of patients participated in the clinical trial program, including those who are inadequate responders to methotrexate, inadequate responders to conventional synthetic disease modifying anti rheumatic drugs (csDMARDs), or inadequate responders to biological disease modifying anti rheumatic drugs (bDMARDs) including TNF inhibitors. The $65 million milestone payment that was to be paid by Lilly to Incyte upon positive CHMP opinion will now be triggered by the granting of marketing authorization by the EU Commission per a recent amendment to the parties' Agreement.


Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization: 2017-02-13

Favourable opinion UE: 2016-12-15

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes