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LLY/INCY Announce Positive Top-Line Results From Phase 3 Trial of Baricitinib (JAK1/2) in Moderate to Severe Rheumatoid Arthritis

INDIANAPOLIS, Dec. 9, 2014 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) today announce that the Phase 3 RA-BEACON study of the investigational medicine baricitinib met its primary endpoint of improved ACR20 response compared to placebo after 12 weeks of treatment. The study included patients with moderately-to-severely active rheumatoid arthritis (RA) who previously failed one or more tumor necrosis factor (TNF) inhibitors and who were taking stable doses of conventional disease-modifying anti-rheumatic drug (cDMARD) therapy. The companies will share results of several ongoing Phase 3 studies in various disclosures in 2015.

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The incidence of serious adverse events with baricitinib treatment, including serious infections, was similar to placebo. There were no opportunistic infections or gastrointestinal perforations in the study. A higher incidence of treatment-emergent adverse events was observed with baricitinib compared to placebo. The most common adverse events observed with baricitinib were headache, upper respiratory tract infection and nasopharyngitis. Discontinuation rates due to adverse events were similar between treatment groups. A large majority of patients completing this 6-month trial opted to participate in a long-term extension study.

http://investor.incyte.com/phoenix.zhtml?c=69764&p=irol-newsArticle&ID=1996010