Biotech bets on sickle cell disease drug getting swift approval
US biotech Global Blood Therapeutics is pretty confident that it will have important regulatory news on its sickle cell disease (SCD) candidate voxelotor by Christmas.
The positive top-line data from Part A of its Phase III HOPE study suggest there is good reason for the company’s confidence.
On the primary endpoint of the proportion of patients with greater than 1 g/dL increase in hemoglobin versus baseline, a statistically-significant increase was demonstrated with voxelotor at both the 1,500mg and 900mg doses after 12 weeks of treatment versus placebo.
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