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AstraZeneca、Bristol再次向FDA提交其糖尿病药物dapagliflozin

来源:生物谷 2013-07-26 23:21

2013年7月26日讯 /生物谷BIOON/ --AstraZeneca公司和Bristol-Myers Squibb公司将再次向FDA提交其研发的治疗二型糖尿病的新药dapagliflozin,这种新药是通过控制肾脏中一种转运葡萄糖的转运蛋白SGLT-2来达到控制血糖的作用的。目前该药物在欧盟澳大利亚等地已经获得批准上市,但是由于美国FDA在糖尿病药物上的严格标准,dapagliflozin一直未能通过。随着Johnson & Johnson's公司一项SGLT-2药物获得通过,dapagliflozin获得批准的可能性也随之增加。(生物谷Bioon.com)

详细英文报道:

AstraZeneca ($AZN) and Bristol-Myers Squibb ($BMY) are trying once again to get U.S. approval for their drug dapagliflozin, an innovative but potentially risky treatment for Type 2 diabetes.

The pharma giants have resubmitted to the FDA a New Drug Application for dapagliflozin, which includes several new studies and four years' worth of data from previously submitted studies.

As obesity rates in the U.S. grow, there is a significant unmet need for diabetes treatments. Nearly half of treated patients do not adequately control their glucose levels.

An investigational compound, dapagliflozin works in the kidney to selectively inhibit the sodium-glucose transport proteins (SGLT2), removing excess glucose and calories in the urine. By removing this excess glucose, dapagliflozin helps to reduce blood sugar levels. The drug works independently of insulin.

In November 2012, the European Union approved the drug under the name Forxiga--the first of its kind to gain regulatory approval. The drug is also approved to treat Type 2 diabetes in Australia, Brazil, Mexico and New Zealand. But the FDA rejected its approval in January 2012, citing concerns about patients who developed breast and bladder cancer in clinical trials and demanding that AstraZeneca and Bristol-Myers produce more data.

The FDA has long held diabetes drugs to high safety standards, but with the approval of Johnson & Johnson's ($JNJ) rival SGLT2 inhibitor in March, U.S. regulators may be warming up to the hot new class of drugs.

 

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