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UK Approves BioCryst's Orladeyo To Prevent Attacks In Hereditary Angioedema Patients

BioCryst Pharmaceuticals Inc. (BCRX) said Wednesday that it has received an approval from the United Kingdom's Medicines and Healthcare products Regulatory Agency for its oral, once-daily Orladeyo or berotralstat for the routine prevention of recurrent hereditary angioedema or HAE attacks in HAE patients 12 years and older.

In the pivotal Phase 3 APeX-2 trial, ORLADEYO significantly reduced attacks at 24 weeks, and this reduction was sustained through 48 weeks. HAE patients who completed 48 weeks of treatment (150 mg) saw reductions in their HAE attack rates, from a mean of 2.9 attacks per month at baseline to a mean of 1.0 attacks per month after 48 weeks of therapy.

In the long-term open label APeX-S trial, patients completing 48 weeks of therapy (150 mg) had a mean attack rate of 0.8 attacks per month.

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