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FDA accepts cardiovascular profile for diabetes drug
02 Apr 2009
Regulatory Affairs
AstraZeneca and Bristol-Myers Squibb's application for approval of their type-two diabetes drug is pressing ahead after the US Food and Drug Administration (FDA) decided that heart disease is not a dangerous side-effect.
The regulatory body's metabolic drugs advisory committee ruled that the data submitted was sufficient to rule out any unacceptable cardiovascular risk relative to the comparators in the programme but also recommended post-marketing trials to monitor heart-related problems associated with the treatment.
AstraZeneca and Bristol-Myers Squibb are currently working on phase-three (b) and stage four studies and say they will work with the FDA to design a further trial to confirm Onglyza's cardiovascular profile.
Howard Hutchinson, chief medical officer at the Anglo-Swiss firm, says the companies are encouraged by the advisory committee's recommendation.
"AstraZeneca and Bristol-Myers Squibb are committed to delivering new therapeutic options that offer real benefits to patients and healthcare providers," he adds.
Meanwhile, the FDA's oncologic drugs advisory committee has this week recommended the accelerate approval of Genentech's brain cancer drug, Avastin.
