Roche's GLP-1 taspoglutide posts good results for A1c control, weight loss, but safety concerns persist
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Once-weekly taspoglutide, Roche's bid to diversify into the diabetes market, controlled blood glucose as well as or better than more frequent treatments with Sanofi-Aventis' Lantus (insulin glargine), Lilly/Amylin/Alkermes' Byetta (twice-daily exenatide) or Merck's Januvia (sitagliptin) in Phase III studies reported at the American Diabetes Association scientific sessions in Orlando, Fla., June 26 (1Health News Daily, June 29, 2010). Compared to Januvia and Lantus, taspoglutide patients also lost significantly more weight, while the performance on that measure was about the same as with Byetta. Safety data from those same trials, however, gave new weight to the announcement earlier in the month that Roche has instituted a risk management plan in its Phase III trials in response to hypersensitivity reactions connected to the glucagon-like peptide-1 analogue (2"The Pink Sheet" DAILY, June 18, 2010). In three studies, patients taking taspoglutide had a significantly greater incidence of nausea and vomiting, as well as injection site skin reactions, compared to those taking comparator drugs. Data presented were from the first 24 weeks of 52-week trials; the full report will be available later in the year, when Roche hopes to have a better handle on the product's safety profile
You may also be interested in...
Roche's Wildcard GLP-1 Not A Spoiler After All; Amylin Stock Soars On Taspoglutide Setback
Roche has voluntarily initiated a risk mitigation strategy to identify patients likely to develop troublesome hypersensitivity reactions and estimates a 12-18 month delay in the development program for the type 2 diabetes therapy.
Biden Extends Helping Hand To Small US Manufacturers, Vendors With ‘Made In America’ EO
The president’s executive order aims to give smaller companies a leg up over foreign competitors, among other objectives.
Warning Letter Roundup & Recap – 26 January 2021
No device-related warning letters were released by the US FDA the week of 26 January.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: