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The FDA's committee of experts met Tuesday to discuss long-term safety data for AstraZeneta's diabetes drug Ongliza and Takeda's diabetes drug Nesina. The committee voted unanimously that prescription labels for both drugs should be updated to include the risk of heart failure.
committee of experts found that neither Onglyza nor Nesina increased the risk of cardiovascular death, stroke or heart attack. But the data showed that Onglyza was associated with a statistically significant increased risk of heart failure, and Nesina showed an increased risk of heart failure, but not statistically significantly.
some members of the committee said that while the risk of heart failure observed by Nesina was moderate, they suspected that it might be a common risk for all DEP-4 inhibitors and that it was worth adding both drugs to the heart failure risk information. However, the Committee of Experts did not recommend limiting onglyza or Nesina's prescriptions.
AstraZeneta Ongliza, Takeda Nesina and Nanuvia of Mercedon are among the DPP-4 inhibitors, whose long-term safety data are expected to be released in June. AstraZeneta rose 3.2 percent in the U.S. after the FDA's expert committee's comments, Takeda closed down 0.67 percent and Mercedon rose 1.8 percent.
analysts believe that sales of DPP-4 inhibitors are likely to continue to grow as neither Onglyza or Nesina has serious safety issues and therefore will not have a material impact on current prescription trends.
Friday, the FDA issued a preliminary review that found that Onglyza had an increased mortality rate. The Committee of Experts, which has responded more modestly to the problem, found that the causes of death were manifold and that diabetics themselves were prone to heart disease, making it difficult to assess whether the risk was real or merely a statistical coincidence.
the FDA is under no obligation to follow the recommendations of its expert committee when making a final review decision, but usually does so. (Bio Valley)