Fda Decided To Extend The Time To Review The Nda Material
, But the body 23, said that as data capacity
, manpower, decided to extend the 3 months time to review the drug's NDA (new drug application) materials.
Prasugrel lucky By the Bristol-Myers Squibb and Sanofi - Aventis Cooperation Sales of clopidogrel (trade name: Plavix Plavix), annual sales of 8 billion U.S. dollars, second only to Pfizer's Lipitor's selling drugs. Great demand for the drug market, doctors know what the drug's efficacy and risks, has been used to develop a certain prescription.
However, even if prasugrel is approved, its sales have to withstand a market test, the situation can quickly turn on the drug's approval depends on the degree of a doctor, compared the advantages and disadvantages of clopidogrel patients and doctors on the status of the comprehensive judgments. Plus clopidogrel cheap generic drugs market in 2011, expensive harder to convince patients with prasugrel (at least in terms of some of the patients).
Therefore, Eli Lilly and its partners were eager to prasugrel first three FDA clearance to market as soon as possible to promote, and looting in the generic drug before, so some doctors and patients to use up first. Lilly is responsible for prasugrel market promotion AnthonyWare manager told "The Wall Street Journal", FDA currently "require additional analysis (treatment of existing clinical data), rather than reinvent the wheel (requiring new data)." Has to be asked to do the correlation processing.
Industry believes that special emphasis on drug safety in today's environment, FDA granted a period of 3 months of delay in approval, appears to be quite to the face, and be very minor deal, no fuss. Its been a "letter of approval", this drug may be "conditional" approval (usually FDA will require pharmaceutical companies to provide more clinical data, or a new clinical research), would not receive the required 3 Final results of months of waiting for a letter from it. From this angle, the ceremony to be the midst of sadness.
Clopidogrel temporary decompression Thrombolytic therapy is indeed a difficult problem, good results often have other side effects of drugs. Last November, Lilly announced a nearly 7,000 by the results of clinical trials involving patients: patients taking prasugrel could reduce about 12.1% of cardiovascular disease risk in patients taking clopidogrel can reduce the risk of 9.9%. However, the incidence of bleeding, prasugrel was 1.4%, 0.9% clopidogrel group.
FDA review may face a dilemma problem. From the efficacy perspective, of course, should be listed on the approval prasugrel, but a large group of patients to use, bleeding risk may result in more patients facing death threats, which is FDA's most concerned about, from the pharmaceutical News Network. Now the market drugs to sell, set aside a number of ways careful to verify the drug did not bring a lot of drug safety issues, not later than the time re-approval also.
Evident from the FDA of this decision to benefit the Bristol-Myers Squibb and Sanofi - Aventis, Eli Lilly's new drug more night city, the more easy to sell their drugs. As far as the patent expired before selling earn more, and perhaps the only hope for the two companies as a sales loss of up to 80 million worth of products, often it is difficult to immediately find a substitute.
In the June 23 ceremony to announce the news of FDA extended the review, Lilly's stock price fell in the first 2 days of 1.4%, to close at 46.94 U.S. dollars, setting a 52-week low. Daiichi Sankyo's stock price fell 2.3%. On the contrary, Sanofi - Aventis shares rose 1.7%, Bristol-Myers Squibb shares up more than 2 days after another 5%.
Fda Decided To Extend The Time To Review The Nda Material
By: zzj89@foxmail.com
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