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Bristol Myers Squibb withdraws diabetes drug from development
Bristol-Myers Squibb has withdrawn its type-two diabetes drug muraglitazar because it requires further trials that would take too long, according to the company.
The drug, developed in collaboration with Merck, had been the subject of an additional information request about its cardiovascular safety profile from the FDA before it could be granted regulatory approval. Bristol-Myers Squibb considered that several analyses of existing studies, comparison tests and clinical studies would be necessary for the drug to be approved.
The company said it had decided to cancel the development of the drug given the time this would take. A statement read: “Based on this assessment, the company’s commercial evaluation of other diabetes alternatives likely to be available in five years and consideration of competing development opportunities in the company’s portfolio, Bristol-Myers Squibb has decided to discontinue the compound’s development.”
In May last year, Bristol-Myers Squibb reported that the drug “significantly decreased” haemoglobin A1C levels, which is a measure of average blood glucose levels over a two or three-month time period.
However, in October 2005, the FDA requested further safety information. In response, Bristol-Myers Squibb said it would begin discussions to terminate the deal with Merck to develop and market the muraglitazar and it added: “The additional studies could take approximately five years to complete.”
Two weeks ago AstraZeneca cancelled the development of Galida, another drug for type-two diabetes, as it said that it did not offer enough benefits over currently available drugs.
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