BioCryst Pharmaceuticals (BCRX) said Monday that interim trial data showed that an oral granule formulation of Orladeyo (berotralstat) demonstrated sustained reductions in monthly attack rates in pediatric patients aged 2 to less than 12 with hereditary angioedema.
After taking Orladeyo for one month, median and mean monthly attack rates dropped to 0 and 0.5 attacks per month, compared with 0.96 and 1.5 with standard-of-care, the biotechnology firm said.
The median attack rate remained at 0 through month 12, the company said, adding that Orladeyo's oral granule formulation was found to be safe and tolerated.
"We remain on track to submit our new drug application to the FDA this year," said Helen Thackray, chief research and development officer of BioCryst.
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