decision to move to Phase III 6/08; Roche stating drug does not have same risks as liraglutide (4/09); primary endpoint met in 1st phase III trial (10/09); results from 2 further phase III trials show drug met A1C primary endpoints compared to Januvia (12/09); favorable top-level results from 5 phase III trials released 2/10; decided to hold NDA submission until 2011, most likely b/c of updated FDA requirements that diabetes drugs in trials assess cardiovascular risk (2/10); showed blood glucose levels were better controlled after 24 weeks vs placebo, as reported 4/10; reached its primary endpoints 6/8 late-stage trials and will present data at ADA in 6/10; drug approval will likely be delayed to 2014, as trials have been delayed 18 months due to hypersensitivity issues, including skin reactions and digestive symptoms, as a REMS program was initiated 6/10
Brand N/A Generic taspoglutide
Company name Roche, Ispen Product type Non-speciality
Therapeutic category Endocrine and Diabetes Key uses Diabetes
Other Uses N/A Drug Class glucagon-like peptide 1 (GLP-1) analog
Dosage From SC, weekly Expected Approval 2012+
FDA Filing N/A Last Update date June 22,2010
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