Lilly Drug Receives Approval in Japan

Posted: Updated:
INDIANAPOLIS -

The Japan Ministry of Health, Labor and Welfare has granted Indianapolis-based Eli Lilly and Co. (NYSE: LLY) and Delaware-based Incyte Corp. (Nasdaq: INCY) marketing approval for a once-daily treatment of rheumatoid arthritis. Lilly says the approval for Olumiant is based on four phase 3 clinical trials.

The approval is for 2-mg and 4-mg tablets of Olumiant, also known as baricitinib, which Lilly says will be used by patients with inadequate responses to standard-of-care therapies. The pharmaceutical company says the clinical trials included more than 3,000 moderate-to-severe RA patients throughout the world, including more than 500 from Japan.

"Today is an important milestone for the RA community in Japan," said Christi Shaw, president of Lilly Bio-Medicines. "Olumiant has been shown to provide effective relief of RA symptoms in people who do not respond to standard treatments, as well as prevent the structural damage to joints that makes RA a progressive, debilitating disease."

Lilly says the approval triggers a $15 million milestone payment from Lilly to Incyte, which is expected to occur in the third quarter.

Earlier this year, the U.S. Food and Drug Administration rejected a new drug application for the treatment, saying more clinical results were needed. 

  • Perspectives

    • Want to Lower Your Medicare Premiums?

      If you’re nearing retirement age, health insurance and Medicare are probably on your mind as well. Do you understand how Medicare works and how the monthly premium is determined? You need to be in the know to avoid making costly mistakes. Here are some tips for potentially lowering your Medicare premiums.

    More

Subscribe

Name:
Company Name:
Email:
Confirm Email:
HTML
INside Edge
Morning Briefing
BigWigs & New Gigs
Life Sciences Indiana
Indiana Connections
INPower
Subscribe
Unsubscribe

Events



  • Most Popular Stories

    • Photo courtesy of Key Detail

      Internationally-Known Artists to Paint Greencastle Mural

      Key Detail, an internationally known mural artist, has been selected to create one of Indiana’s largest murals on four large grain silos at the corner of Veterans Memorial Highway and U.S. 231 in Greencastle. The Putnam County Mural Project received more than 70 applications from muralists worldwide for the project, which is a canvas of up to 8,000-square-feet and a primary gateway for Greencastle.  

    • Alexa Deaton and Colby Shank

      Higher Ed Commission Promotes Two

      The Indiana Commission for Higher Education has promoted Alexa Deaton to associate commissioner and Chief Financial Officer. She previously served as director of accounting. Also, Colby Shank has been promoted to associate commissioner for student financial aid, a new position for the organization. He most recently served as assistant commissioner for financial and student support services.
    • Rob Baker and Ryan Chelli

      Foundation Announces Promotions

      The Community Health Network Foundation has promoted Rob Baker to vice president of foundation operations. He most recently served as executive director of finance. Baker joined the organization in 2016 and received his bachelor of arts degree from Purdue University and law degree from Indiana University School of Law – Indianapolis. Also, Ryan Chelli has been promoted to vice president of donor relations.  

    • Photo courtesy of Purdue University

      Purdue Offers 'Stranger Things' Replica Tee

      Purdue University has partnered with trademark licensing agent CLC to produce a special-edition replica Purdue shirt that appeared on an episode of Netflix’s “Stranger Things 3.”  The university also teamed up with Venley to accurately replicate the shirt, which will be available at retailers on the West Lafayette campus and online later this month.

    • (photo courtesy of The Times of Northwest Indiana)

      Historic Hospital to be Torn Down in Gary

      A building that once represented the racial divide in the city of Gary, but long provided health care to the African American community, will soon fall to a wrecking ball. The city says it intends to raze the long-abandoned St. John’s Hospital.