Corporate Banner
Satellite Banner
Scientific Community
Become a Member | Sign in
Home>News>This Article

Lilly Provides Update on Next Steps for Solanezumab

Published: Thursday, December 13, 2012
Last Updated: Thursday, December 13, 2012
Bookmark and Share
Eli Lilly and Company provided an update on the next steps planned for solanezumab, its Phase 3 monoclonal antibody being studied as a potential therapy for patients with mild Alzheimer's disease.

Following discussions with regulators in the U.S., Europe and Canada, Lilly plans to conduct an additional Phase 3 study of solanezumab in patients with mild Alzheimer's disease. Additional details, including study design and length, are still being determined. Lilly expects to initiate this study no later than Q3 2013.

Based on recent meetings with the U.S. Food and Drug Administration (FDA), Lilly does not intend to submit a Biologics License Application (BLA) at this time in the U.S. based solely on the existing analyses of data from the EXPEDITION studies. Lilly will continue to analyze and discuss the data from the two, Phase 3, double-blind, placebo-controlled solanezumab EXPEDITION studies with regulators globally to determine the regulatory paths forward in different regions. It is possible that different courses of action could be taken in different jurisdictions.

Independent analyses of the Phase 3 solanezumab EXPEDITION data were conducted by the Alzheimer's Disease Cooperative Study (ADCS), an academic research consortium, and presented at the annual meeting of the American Neurological Association (ANA) on Oct. 8, 2012, and at the Clinical Trial on Alzheimer's Disease (CTAD) meeting on Oct. 29, 2012.

"Based on both the independent analyses by the ADCS, as well as our own," said Eric Siemers, senior medical director of Lilly's Alzheimer's disease team, "we believe the results demonstrating a slowing of cognitive decline in patients with mild Alzheimer's disease treated with solanezumab are the first data from Phase 3 clinical trials that support the amyloid hypothesis."

"We remain encouraged and excited by the solanezumab data," said David Ricks, senior vice president and president, Lilly Bio-Medicines. "We are committed to working with the FDA and other regulatory authorities to bring solanezumab to the millions of patients and caregivers suffering from this devastating disease who urgently need this potential treatment."

Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More than 5,200+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Eli Lilly, AstraZeneca to Continue Clinical Trial for Early Alzheimer's
Phase 2/3 trial of AZD3293, an oral potent small molecule BACE inhibitor, will continue to Phase 3 after positive interim safety data.
Monday, April 11, 2016
Lilly Launches Its First Phase III Trial for Treatment of Alzheimer's Disease
Late-stage IDENTITY study of once-daily, oral agent is now enrolling patients.
Wednesday, April 02, 2008
Scientific News
Salford Lung Study - The First Real World Clinical Trial
In this podcast, we learn about the Salford Lung Study and its potential to revolutionize the way we assess new drugs and treatments around the world.
Editing Gene Mutations in Anemia
Researchers successfully use a new gene editing strategy to correct mutations that cause a form of anemia.
Nanomedicine Aims to Improve HIV Drug Therapies
New research aims to improve the administration and availability of drug therapies to HIV patients using nanotechnology.
Observing Direct Inheritance of Gene-Silencing RNA
Research has allowed for the observation of double-stranded RNA molecule being passed from parent to offspring in roundworms.
Fighting Cancer with Immune Response
New treatment elicits two-pronged immune response that destroys tumors in mice.
First Entirely 3D-printed Organ-on-a-Chip with Integrated Sensors
New approach to manufacturing may allow researchers to rapidly design organs-on-chips that match the properties of a specific disease or individual patient's cells.
Nanoparticles Offer Promising Platform for Flavivirus Treatment
New nanoparticle effectively vaccinated mice against one dengue strain and could be created to target all four.
Study Finds Key Regulator in Pulmonary Fibrosis
Researchers identify an enzyme that could open the way to therpies for chronic fatal lung disease.
Signaling Pathway Could Be Key to Improved Osteoporosis Treatment
Inhibition of SIK2 enzyme both stimulates bone formation and reduces bone breakdown in animal model.
Ovarian Cancer Insight
Study showed tumours release cytokines to attract macrophages, which secrete growth factors that in turn promote tumour growth.

SELECTBIO Market Reports
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,200+ scientific videos