GEN Exclusives

More »

GEN News Highlights

More »
Mar 15, 2010

FDA Stalls Approval of Amylin, Lilly, and Alkermes’ Type 2 Diabetes Therapy

  • Amylin Pharmaceuticals, Eli Lilly, and Alkermes reported that the FDA has issued a complete response letter regarding the NDA for exenatide extended-release injectable suspension as a treatment for type 2 diabetes. Bydureon is the proposed brand name for exenatide once weekly.

    In the complete response letter there are no requests for new preclinical or clinical trials, according to the companies. Issues raised in the letter primarily relate to the finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes, they explain. The complete response letter reportedly does not contain requests related to the December 2009 observations from the FDA’s preapproval inspection at the Ohio manufacturing facility. All those observations have been addressed, the firms note.

    “We have a clear path forward and are working diligently to submit our response to the FDA in the next few weeks,” says Orville G. Kolterman, M.D., svp of R&D, Amylin.

    Bydureon is designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. It belongs to the glucagon-like peptide-1 (GLP-1) receptor agonist class of medications.


Related content


GEN Jobs powered by connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
More »

Be sure to take the GEN Poll

Patient Access to Genetic Information

Do you think patients have the absolute right to gain access to their own genetic information from medical or clinical laboratories?

More »