FDA accepts new drug application from GBT's SCD therapy voxelotor
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Last Update: 2020-06-08
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Source: Internet
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Author: User
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Global( http:// announcedthat the u.SFDA(http://had accepted the company's application fornew drug(http://(NDA) for the oral sickle cell anemia (SCD) treatmentAbout Voxelotor
Voxelotor is an innovative SCD innovation that is taken orally every day to achieve efficacy by increasing hemoglobin affinity to oxygenBecause oxygenated sickle hemoglobin does not aggregate, voxelotor prevents sickle changes in red blood cells and damage to red blood cellsVoxelotor has the potential to restore normal hemoglobin function and improve oxygen deliveryVoxelotor has been awarded the U.SFDA for breakthrough therapy, orphan drug eligibility, fast-track eligibility, and rare pediatric disease designations Voxelotor's application is based on the results of the Phase 3 Clinical Trial (http:// named HOPE The results of the trial were published in the New England Journal of Medicine The results showed that 59.5% of patients in the voxelotor patient group who received a dose of 1500 mg had increased hemoglobin levels by more than 1 g/dL Previous studies have shown that lower hemoglobin levels are associated with negative clinical consequences, while increasing hemoglobin levels by 1 g/dL may significantly reduce clinical complications and mortality in SCD patients
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