Diabetes In Control. A free weekly diabetes newsletter for Medical Professionals. News and information for Medical Professionals.
A higher rate of hypersensitivity and GI intolerability was seen with taspoglutide…
Roche has stopped giving patients its experimental diabetes treatment taspoglutide in late stage clinical trials due to a high rate of adverse reactions, marking a major blow to a drug once seen to have $2 billion a year potential.
The Swiss drug maker said that the decision was based on a higher-than-expected rate of discontinuations due to gastrointestinal (GI) intolerability, and due to serious hypersensitivity reactions experienced by some patients, according to 52-week data from the trials.
“These discontinuation rates compromise interpretation of the long term safety data from the T-emerge studies, therefore continuing treatment with the current taspoglutide formulation is not considered to be in the best interest of patients,” Roche said in a statement.
If Phase III dosing has been suspended this is the final blow for what was perceived as a compound in trouble after the disappointing data on hypersensitivity and nausea/vomiting presented at the American Diabetes Association meeting this year.
The drug, given once weekly by injection, suffered a serious setback in June when it was reported that there were cases of patients suffering hypersensitivity reactions to the medicine in clinical trials.
The latest blow to Roche is seen as a boon to Amylin Pharmaceuticals, Inc., and Eli Lilly and Co., which are awaiting a U.S. approval decision for their once-weekly, injectable diabetes drug Bydureon.
Roche said it was not abandoning its drug, but was considering a reformulation of the medicine. Any reformulation would likely cause a significant delay beyond the one Roche signaled in June when the hypersensitivity data was revealed at the ADA meeting. At that time Roche said the setback would likely cause a delay in filing for approval of a minimum of 12 to 18 months. It had previously been aiming to apply for taspoglutide approval worldwide in 2011.
While the percentage is low, as with the GI problems, the number was higher than expected, Roche said. The most frequently reported symptoms in patients who developed hypersensitivity reactions were skin reactions, nausea, and vomiting, while cardiovascular and respiratory symptoms were less frequent, Roche said.
Reuters