The Swiss pharmaceutical company says it is not abandoning taspoglutide. In an announcement the company said it is considering a reformulation of the medication. However, any kind of reformulation will most likely result in a significant delay in the approval process and date.
Taspoglutide was predicted to become a blockbuster, with annual sales exceeding $2 billion per year. This suspension is seen as a major blow for both Roche and Ipsen.
Roche reported on Friday that the rate of discontinuations due to gastrointestinal intolerability and serious hypersensitivity reactions experienced by some trial participants, led to a decision to suspend the trial.
In a written statement, Roche informed:
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.
Earlier on this year disappointing data had been presented at the American Diabetes Association revealing hypersensitivity, nausea and vomiting among patients taking the experimental drug. Patients were receiving a once-weekly injection.
Taspoglutide is a glucagon-like peptide-1 analog drug under investigation for treatment of type 2 diabetes.
According to media reports, shares in the French pharmaceutical company, Ipsen fell 3% today.
Written by Christian Nordqvist