COPENHAGEN (Reuters) — American regulators dealt a major blow to the hopes of Novo Nordisk, the Danish drug maker, for its new long-acting insulin Tresiba by demanding that it conduct additional clinical tests to assess potential heart risks.
Novo, the world's biggest insulin maker, said the Food and Drug Administration had requested additional data from a dedicated cardiovascular outcomes trial before it would consider approving Tresiba and a related product, Ryzodeg.
The drug maker, which is banking on Tresiba to keep it in the lead in diabetes care, said on Sunday that it did not expect to be able to provide the data during 2013. Analysts said the F.D.A.'s stance could delay Tresiba until 2015 or 2016.
"They will have to make new studies and that will delay the launch of Tresiba in the U.S. by two to three years," said Soren Hansen, an analyst with Sydbank. "It is a really bad situation."
The setback for Tresiba, also known as degludec, is good news for rival makers of insulin medicines, including France's Sanofi. A Sanofi product, Lantus, is under threat from Novo's newer ultra-long-lasting treatment.
Most investors had expected an approval from the F.D.A., after an advisory panel to the agency made a positive recommendation last November.
Optimism about Tresiba and Ryzodeg — which combines degludec with another formulation of insulin — was further bolstered by final approval in Europe last month. They have also been approved in Japan.
Tresiba and Ryzodeg have been widely predicted by analysts to become multibillion-dollar sellers worldwide.
The F.D.A.'s decision to issue Novo a so-called complete response letter therefore confounded consensus expectations. Such letters are issued when the agency determines that an application cannot be approved in its existing form.
"We are surprised and disappointed to receive this letter, but we acknowledge this decision by the F.D.A. and will work with the agency to determine the best path forward to completing the review," Novo's chief executive, Lars Rebien Sorensen, said in a statement.
Concerns about the cardiovascular safety of Tresiba are not new, but Novo and most analysts had thought the issue had been resolved.
The F.D.A. advisers meeting last year expressed concern about a trend toward higher incidence of adverse heart events with the new insulin than with older types. The differences seen in 16 large clinical trials, however, were not statistically significant.
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