After the FDA’s decision to issue a CRL to Eli Lilly in April, 2017 for its JAK inhibitor, baricitinib, (a decision we discussed at the time: here) the agency announced that the drug will be the subject of an arthritis advisory committee (AAdCom) meeting a little more than 12 months later1.
If baricitinib is ultimately approved by the agency, it is likely to become the second JAK inhibitor to reach the U.S. market, behind Pfizer’s Xeljanz, which is already approved by the FDA for rheumatoid arthritis (RA) and psoriatic arthritis (PsA), and is currently under review for ulcerative colitis (UC) following a successful FDA advisory committee meeting on March 8.
The Decision Resources Group Immune and Inflammatory team will be conducting a launch-tracking study following the launch of baricitinib for RA, conducting surveys at one-month, six-months, and one-year post-launch.
Rheumatoid Arthritis | Emerging Therapies | baricitinib (Rheumatoid Arthritis) | US
This study will complement our ongoing launch-tracking study of Xeljanz for PsA, the first wave of which will publish at the end of March, 2018 and a planned study in UC. We also conducted a launch-tracking study of Xeljanz for RA between 2012 and 2014.
Psoriatic Arthritis | Emerging Therapies | Xeljanz (Psoriatic Arthritis) | US
Rheumatoid Arthritis | Emerging Therapies | Xeljanz (Rheumatoid Arthritis) | US
Ulcerative Colitis | Emerging Therapies | Xeljanz (Ulcerative Colitis) | US
For questions on these launch-tracking series or other DRG content, please contact: email@example.com
- https://endpts.com/eli-lilly-gets-a-date-with-fda-experts-for-once-rejected-rheumatoid-arthritis-drug-baricitinib/ Accessed March 16, 2018