An FDA advisory panel is scheduled to review AstraZeneca and Bristol-Myers Squibb’s DPP-4 inhibitor Onglyza (saxagliptin) on April 1, and Novo Nordisk’s mimetic incretin compound Victoza (liraglutide) on April 2. Mads Krogsgaard Thomsen, Novo Nordisk’s chief scientific officer, suggested that Victoza may be well positioned for the review because the company’s existing studies for the drug may meet the FDA’s stricter, updated guidance calling for drugmakers to provide evidence that new type 2 diabetes treatments do not increase the risk of cardiovascular events.
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Thomsen said results from studies of Victoza, which involved more than 6500 patients, demonstrated that the drug does not increase, and may in fact lower, cardiovascular risk. In addition, the absolute risk for the drug was found to be equal to or lower than comparison treatments used in the trials. Thomsen said the FDA has not told Novo Nordisk that new studies are needed to meet the agency’s guidance.
Regarding Onglyza, AstraZeneca and Bristol-Myers Squibb declined to provide details about studies on the drug, which involved more than 5000 patients, saying only that the trials are comprehensive and showed no signs of cardiovascular risk. The companies also remarked that the FDA has not requested additional testing on Onglyza.
Commenting on the prospects for Novo Nordisk’s drug, analyst Jack Scannell of Sanford C. Bernstein & Co. remarked that Victoza’s review by the advisory panel is “not a dead certainty,” judging from the FDA’s recent request for Takeda to provide more data on its DPP-4 inhibitor alogliptin. In addition, Peter Verdult of Citigroup Global Markets has suggested that regulators may have difficulty accurately comparing Victoza to other drugs given to patients in testing, given the low number of heart attacks, strokes and deaths observed in the patients involved. “The risk remains that pre-approval studies are required…we still see the benefit/risk profile as unfavourable going into April’s FDA advisory committee meeting,” he added.
Source: FirstWord
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