AstraZeneca said the FDA approves its blood-thinner experimental Brilinta without further analysis of data, even if the agency requests that society conduct additional clinical trials.
In July, one of the advisory groups to the FDA voted 7-1 to the approval of the drug, even questions about why the test showed the drug did offer no benefit patients to the United States.
In a statement, AstraZeneca said he evaluated the response of the FDA and provide analyses it seeks "as soon as possible." Astra said that it was "confident" in his presentation of drugs, also known as ticagrelor and in its ability to respond to questions from the Agency."
Astra, says the FDA wants in addition to the analyses trial PLATO called, who developed the test Brilinta against Plavix market 18,624 patients in 43 countries. It is unclear what aspect the Agency wants to detail, although Bernstein analyst Tim Anderson said in a note to research the performance of the drug in patients in the U.S. can be a key issue. Wrote: "there remains a possibility that the United States patients are treated differently from those outside the United States and for any reason whatsoever, this parlays in Brilinta being does not as good as Plavix, current standard-gold".
The drug is approved for use in Europe.
Dow Jones Newswires reports, this is not good news for the company. Jefferies, explains a delay under the u.s. approval of at least six months of shaving 200 million in annual turnover of Astra in 2011.
As Ron Winslow in the WSJ reported earlier this year, there are big issues on the market of anticoagulants. Approximately $ 8.6 billion value of Plavix was sold last year. But the drug is now a black box warning to warn doctors who, between 2% and 14% of users do not receive, and he loses patent protection next year. Eli Lilly and Novartis are also in the hunt to market with their own medication.
Photo: Associated press
No comments:
Post a Comment