As was reported in the Marketletter last week (March 17), the UKMedicines Control Agency was unable to recommend Scotia's drug for diabetic neuropathy, Tarabetic, for approval. It has now been revealed that the principal concerns of the Committee on Safety of Medicines, an advisory panel to the MCA, were whether Tarabetic was efficacious in both insulin and non-insulin dependent diabetes mellitus patients, and whether there is evidence of efficacy if two of the 12 trial centers are excluded from the analysis. Scotia plans to submit the additional data required within the next eight weeks.
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