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

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 3,300+ scientific posters on ePosters
  • More than 4,800+ 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 TechnologyNetworks.com 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
Colon Cancer Blocked in Mice
Case Western Reserve University Researchers block common type of colon cancer tumour in mice, laying groundwork for human clinical trial.
Protein Nanocages Could Improve Drug Design and Delivery
HHMI scientists have designed and built 10 large protein icosahedra that are similar to viral capsids that carry viral DNA.
Development in Preventing Macular Degeneration
Following macular degeneration insight, promising drugs to prevent vision loss have been identified.
Improving Tumour Therapy with Nanoparticles
UHN nanoparticle called PEARLs is a promising utilisation of photo-thermal therapy for cancer treatment.
New Antidepressant Treatment Discovered
Scientists have demonstrated how gene therapy could lead to new treatments for depression.
Cellular Origin of Skin Cancer Identified
Scientists have identified ‘cell of origin’ in the most common form of skin cancer, and followed the process that leads to tumour growth.
Enhancing Drug Safety with a Web-Based Data Tool
Online and open-access tool allows anyone to find, combine and analyse FDA drug information.
Genetic Missing Link Could Explain Mystery of Heritability
Mother’s diet during pregnancy can permanently affect offspring attributes through process that could be strongly influenced by genetic variation in an unexpected part of the genome.
Does the Transport of Next-Gen Vaccines Lie with E.coli?
Study shows harmless E.coli capsule could aid next-gen vaccine delivery and efficiency.
Breathing in a Cure
Researchers working on inhalable ibuprofen to treat cystic fibrosis.
SELECTBIO

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
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,800+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!