FDA awarded the breakthrough drug qualification of genetirizumab
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Last Update: 2014-12-19
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Source: Internet
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Author: User
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Source: Ding Xiangyuan, Dec 19, 2014, US FDA awarded the qualification of rapunzumab, a gene trek VEGF inhibitor, as a breakthrough drug for diabetic retinopathy The drug has been granted priority review in the United States, and its breakthrough treatment drug qualification will help to further accelerate its FDA review In essence, the move suggests that FDA believes that early data on rapunzumab shows that the drug will provide a significant improvement in disease compared to existing therapeutic drugs, and may help to meet significantly unmet medical needs Currently, there is no approved treatment for diabetic retinopathy, which affects about 7.7 million Americans If approved, it would be every four indications for rapunzumab, which has been marketed outside North America by Novartis since 2006.
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