Lilly Granted Priority Review For Headache Treatment

Posted: Updated:
The drug received FDA approval for migraine treatment in September. The drug received FDA approval for migraine treatment in September.
INDIANAPOLIS -

Indianapolis-based Eli Lilly and Co. (NYSE: LLY) says one of its headache treatments is moving closer to approval. The U.S. Food and Drug Administration has granted Priority Review for a drug to be used for the preventative treatment of episodic cluster headache in adults.

Lilly says if its supplemental Biologics License Application for the drug Emgality is approved, it could potentially represent a significant advancement in treatment for a serious condition. Emgality is an injection treatment that received FDA approval in September to treat migraine in adults.

Emgality also received Breakthrough Therapy Designation from the FDA in September for the treatment of episodic cluster headache. The pharmaceutical giant says episodic cluster headache is a disabling disorder that affects about 124 per 100,000 adults.

"Cluster headache is a severely disabling and excruciatingly painful neurological disorder. Few treatment options are available, and only a limited body of research from rigorous clinical trials exists," said Gudarz Davar, vice president of neurology development at Lilly Bio-Medicines. "We are pleased the FDA has granted Priority Review for our sBLA, acknowledging the need for new treatments for this devastating disease and bringing us closer to potentially offering a preventive treatment option for these patients."

Lilly says it is currently recruiting for Phase 3 studies to evaluate Emgality for the prevention of migraine in children and adolescents, aged six to 17.

  • Perspectives

    • Startup Spirit Fuels Growth

      As the South Bend - Elkhart Region celebrates a $42.4 million grant from Lilly Endowment Inc., we know that the work to make the best investment with it is really just beginning. The spirit of entrepreneurship has been a vibrant part of our region for decades and the story of our family company could be somewhat of a guidebook for the region as it ventures forward. ITAMCO began as a dream of my uncle Donald Neidig and my father Noble Neidig to have their own business.

    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

    • The Waterside project aims to transform 100-acres of the former GM Stamping Plant site. (photo courtesy of Ambrose Property Group)

      Ambrose, Glick Partner on Waterside

      Indianapolis-based Ambrose Property Group has announced a key partnership for the redevelopment of the former GM Stamping Plant in downtown Indianapolis. The commercial real estate firm is teaming up with the Gene B. Glick Co. to build and manage apartments as part of the $1.4 billion mixed-use redevelopment project. Ambrose says the partnership is also part of plans to catalyze "philanthropic and community-centric strategies to strengthen Indianapolis." The firm also...

    • NIBCO is headquartered in Elkhart. (photo courtesy of NIBCO)

      Companies Detail Closures, Layoffs

      Four companies have announced plans to lay off a total of nearly 300 employees. In separate notices filed with the state, the companies say the moves will affect workers in Indianapolis, Fort Wayne, Charlestown and Peru.

    • (Rendering provided by the city of Fishers.)

      Flexware to Break Ground on Headquarters

      Fisher’s based engineering servicing firm, Flexware Innovation Inc., will break ground Thursday on its new headquarters the Nickel Plate District Amphitheater. The $3.5 million project will feature a 35,000-square-foot office building with 12,000-square feet of office space for Flexware and what it calls “a build-to-suit area” in the remaining space. 

    • (rendering courtesy of Brightmark Energy)

      Construction to Begin on Plastics-to-Fuel Plant

      California-based Brightmark Energy will today break ground on its $260 million plastics-to-fuel plant in the northeast Indiana town of Ashley. The 112,000-square-foot facility, which the company says will be the first of its kind in the nation, is expected to create 136 full-time jobs when fully operational. The plant will use a state-of-the-art process to recycle plastic waste that has reached the end of its useful life, including items that normally cannot be recycled, such as...

    • Photo courtesy of Lafayette Elementary School

      Hammond to Close Three Schools, to Cut Jobs

      The  School City of Hammond board has voted to close three schools and cut 130-150 positions. Our partners at The Times of Northwest Indiana report Columbia and Lafayette Elementary schools, and the Miller School will close after this school year.