Lilly Continues Positive Outlook For Migraine Treatment

Posted: Updated:
INDIANAPOLIS -

Indianapolis-based Eli Lilly and Co. (NYSE: LLY) says a 12-month Phase 3 study of a migraine treatment has shown continued positive results. The pharmaceutical giant says the study for galcanezumab showed a "statistically significant reduction in the number of monthly migraine headache days" among patients.

Lilly says the treatment "demonstrated a positive safety and tolerability profile in patients with migraine, consistent with previous studies." Patients received two different doses and the company says there was "no clinically meaningful difference" in the rate of adverse effects between the dosages. 

Lilly's previously-announced plans to submit a Biologics License Application to the U.S. Food and Drug Administration remain set for the second half of 2017. The company also plans to submit to other regulatory agencies throughout the world.

"These long-term results are significant for the millions of Americans with migraine. They reinforce the efficacy and safety profile of galcanezumab while supporting its potential use as a self-administered, monthly injection," said Christi Shaw, president of Lilly Bio-Medicines. "After more than two decades of research, Lilly is excited to submit galcanezumab to the FDA as a new potential treatment option that can provide more migraine-free days for people suffering with migraine."

Lilly is presenting the results of the study at the 18th Congress of the International Headache Society in Vancouver. The company also plans to submit the findings for publication in a peer-reviewed journal "in the coming year."

The announcement comes just one day after Lilly detailed plans for a global restructuring, affecting about 3,500 employees. The company said the move will allow it to invest in the next generation of new medicines.

  • Perspectives

    • #MeToo, Bullying And What We All Can Do Now

      Indeed, it is an interesting time with so much continuing to come out in Hollywood, the media, other industries, and even our state government related to the sexual harassment of women - women who have remained silent for years. Like those women, I too have been harassed in various ways over the course of my career, even in recent years - and yes, even in top leadership roles. The headline about my departure or the email citing that I was moving on never fully told the real story.

    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

    • U.S. Steel 'Renaissance' Spurs $750M Gary Works Investment

      Pittsburgh-based U.S. Steel Corp. (NYSE: X) has announced a $750 million investment in its Gary Works operations. The company says the funds are part of a $2 billion asset revitalization effort that will take place over the next five years. Last year, U.S. Steel detailed plans that involved pumping $35 million into Gary Works, which followed the $23 million first phase of its Hot Strip Mill Restoration Plan. The latest investment, the Indiana Economic Development Corp. says...

    • Salesforce Begins Pathfinder, Reorganization Efforts

      Salesforce.com Inc. (NYSE: CRM) is underway with the first cohort of its Pathfinder Training Program that is part of the tech giant's ongoing Indianapolis growth. The company is partnering with Deloitte to provide business and technical training to Ivy Tech Community College students and Hoosier veterans looking to become Salesforce administrators and developers. The program comes as the company realigns its Marketing Cloud organization. In a statement, Salesforce says it...

    • Hoosier Schools Among 'Best Colleges in America'

      Nearly two dozen Hoosier institutions are included in MONEY magazine's rankings of the Best Colleges in America. More than 700 schools are on the list, which was determined by a number of factors in three categories, including quality of education, affordability, and outcomes.

    • Geovani Bonilla

      IU Health Plans Names VP

      Geovani Bonilla has joined Indiana University Health Plans as vice president of medical operations. He previously served as director of utilization management for Johns Hopkins Healthcare.

    • Fort Wayne Radio Icon Butcher Passes Away

      A fixture in the Fort Wayne radio scene has passed away. Charly Butcher spent more than 30 years in Fort Wayne radio with a successful morning show on WMEE-FM and, most recently, as host of "Fort Wayne's Morning News" on WOWO radio. Butcher was 61. Butcher was part of WMEE's popular "Those Two Guys In The Morning" show with Tony Richards in the 1980s. He joined WOWO in the mid-2000s as host of "Fort Wayne's Morning News With Charly Butcher."