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轉(zhuǎn)：具有全新降低血糖機(jī)制的新藥被fda專家小組否定 已有2人參與
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轉(zhuǎn)自丁香園http://xdrug.dxy.cn/bbs/thread/20653328?keywords=»具有全新降低血糖機(jī)制的新藥被fda專家小組否定#20653328 作者：blueskychina FDA Panel Votes Against Diabetes Pill，Matthew Perrone，Drug Discovery & Development - July 20, 2011 fda15人專家小組昨天9對(duì)6票否定治療糖尿病新藥的決定，其理由是對(duì)此藥可能引發(fā)癌癥的數(shù)據(jù)不足。這不是fda官方最后決定，但是可以看成是官方?jīng)Q定。 此藥具有全新機(jī)制的控制血糖功能，通過清除尿中葡萄糖量而降低血中糖量，此作用機(jī)理和傳統(tǒng)降血糖機(jī)理完全不一樣， 是一類全新降糖藥物，也是這類作用機(jī)理中第一個(gè)藥物。 由于是全新機(jī)制的降血糖藥物，審評(píng)者對(duì)這些數(shù)據(jù)的評(píng)估也沒有很多經(jīng)驗(yàn)，有一個(gè)參入評(píng)審者說在要在做出最后決定之前的10秒鐘他的主意改變了4次，當(dāng)然這是和夸張的說法，但是可以看出對(duì)新機(jī)制藥物要做出正確的決定很艱難，哪怕你有很多可靠的數(shù)據(jù)。 此藥的有效性方面沒有多少疑問。主要關(guān)注在是否引發(fā)癌癥、肝臟毒性和感染方面，數(shù)據(jù)顯示和對(duì)照組比較很難讓人放心，例如在超過5000個(gè)病人中用藥組膀胱癌發(fā)現(xiàn)有9例而非用藥組沒有一個(gè)，這樣的數(shù)據(jù)很明顯表面膀胱癌發(fā)病率和用藥的關(guān)系，特別是在這么大的樣本中。 本人的看法是此藥如果再做癌癥安全方面的實(shí)驗(yàn)，很難通過，因?yàn)楝F(xiàn)有的數(shù)據(jù)已經(jīng)比較清楚說明了膀胱癌和藥物的關(guān)系。個(gè)再做同樣實(shí)驗(yàn)，結(jié)果很難被推翻。 從這樣的臨床實(shí)驗(yàn)看，具有全新機(jī)制的藥物研發(fā)風(fēng)險(xiǎn)很大，而且不可控。嚴(yán)重不良反應(yīng)真的很難預(yù)測(cè)和控制。但是這樣的實(shí)驗(yàn)給后來者奠定了很好的基礎(chǔ)，也許會(huì)少犯同樣的錯(cuò)誤。 其實(shí)在任何一個(gè)臨床試驗(yàn)數(shù)據(jù)里都可以找到很多問題，只要不是核心的就好。在這個(gè)實(shí)驗(yàn)中，有人說老年人和非美籍病例數(shù)太少。如果有了這些數(shù)據(jù)，一定有人會(huì)說亞裔病人太少。問題是在一個(gè)臨床試驗(yàn)中不可能包涵所有情況。 大家猜猜公司還會(huì)繼續(xù)補(bǔ)充安全性方面的數(shù)據(jù)�。课蚁霑�(huì)的，理由是這2個(gè)公司都很有實(shí)力，錢不是最大問題，對(duì)于這樣全新機(jī)制的新藥有效性沒有問題，現(xiàn)在放棄很可惜。 下面是全文： WASHINGTON (AP) - The majority of advisers on a federal health panel say a first-of-a-kind diabetes drug that uses a new method to reduce blood sugar shouldn't be approved for U.S. patients after higher rates of bladder and breast cancer were reported among patients in company trials.A Food and Drug Administration panel voted 9-6 against the experimental diabetes pill from Bristol-Myers Squibb and AstraZeneca, while expressing hope that the drug might ultimately be approved if safety questions are resolved. The vote is only a recommendation for FDA, which will make a final decision on the drug before the end of October. Dapagliflozin is a once-a-day pill designed to help diabetics eliminate excess sugar in their urine. That differs from older drugs that decrease the amount of sugar absorbed from food and stored in the liver. The companies have touted it as the first in a new class of drugs to address the nation's growing diabetes epidemic, which affects more than 25 million people. Nearly all the panelists praised the drug's innovative approach to lowering blood glucose, but a majority said they wanted more information on a host of safety concerns, including cancer, infections and possible liver toxicity. "It was the closest of calls, I changed my mind about four times in the last 10 seconds," said Dr. Erica Brittain, a biostatistician with the National Institutes of Health, who voted against the drug. "The level of evidence about the cancer is fairly weak, but it's just that the uncertainty is still there." The companies reported nine bladder cancers among over 5,000 people taking the drug in company studies, compared with none among those taking a dummy pill. There were nine cases of breast cancer among 2,100 women taking the drug, compared with one in the control group. While the company studies were not designed to measure cancer risk, panelists noted that the incidence of cancers was four to five times higher than expected in the population. Panelists said they would like more data on cancer rates in patients, but acknowledged that a definitive study of the risk probably would not be feasible, since it would mean enrolling more than 30,000 patients for several years. "There are some things we can't learn from clinical trials," said Dr. Ed Hendricks of the Center for Weight Management in Sacramento, Calif., who voted to approve the drug. "Sometimes to introduce new, innovative medical therapies we have to make decisions with a certain amount of uncertainty." The drug was also associated with bladder and urinary tract infections, due to increased sugar eliminated in patients' urine, and the companies suggested this factor may have led to higher detection of bladder cancers. That rationale did not explain why bladder cancers reported were limited to men, since urinary tract infections are more common in women. Panelists also complained about the small number of elderly and African-American patients enrolled in company studies. People in those groups are more predisposed to have diabetes. People with type 2 diabetes are unable to properly break down carbohydrates, either because their bodies do not produce enough insulin or have become resistant to the hormone, which controls blood sugar levels. These patients are at higher risk for heart attacks, kidney problems, blindness and other serious complications. Diabetics often require multiple drugs with different mechanisms of action to control their blood sugar levels. New York-based Bristol-Myers Squibb Co. and London-based AstraZeneca PLC already co-market the diabetes drug Onglyza, which increases insulin production while reducing glucose production. Date: July 19, 2011 Source: Associated Press [ Last edited by 古可ぷ on 2011-9-29 at 22:49 ] |
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