The U.S. Food and Drug Administration (FDA) has accepted Biocryst Pharmaceuticals’ application to approve an oral granule formulation of Orladeyo (berotralstat) for children with hereditary angioedema (HAE) as young as 2. The FDA granted the application priority review, which shortens the process from the standard 10 months…

Biocryst Pharmaceuticals has submitted an application asking the U.S. Food and Drug Administration (FDA) to extend the approval of Orladeyo (berotralstat) to children with hereditary angioedema (HAE) as young as 2 years. The application specifically seeks the approval of an oral granule formulation of the therapy for…

An oral granule formulation of Orladeyo (berotralstat) was safe and well tolerated, and able to reduce the rates of swelling attacks in children with hereditary angioedema (HAE), according to an interim analysis of an ongoing Phase 3 trial. The open-label Phase 3 APeX-P trial (NCT05453968) is assessing the…

The government agency in Portugal that regulates human medicines, Infarmed, has recommended Orladeyo (berotralstat) for the routine prevention of swelling attacks in people with hereditary angioedema (HAE), ages 12 and older. With this positive recommendation, HAE patients in the country will now be able to access Orladeyo treatment.

Orladeyo (berotralstat), an approved oral treatment to prevent attacks in hereditary angioedema (HAE) patients 12 years and older, is one step closer to being eligible for reimbursement under public drug plans in Canada, according to its developer, Biocryst Pharmaceuticals. Biocryst has successfully completed negotiations with the pan-Canadian…

Transitioning from other prophylactic, or preventive, treatments, to Orladeyo (berotralstat) or Takhzyro (lanadelumab) can take some time and adjustment, but helps to safely prevent swelling episodes in hereditary angioedema (HAE) patients. That’s according to a study reporting the process of such a treatment transition for four family members…

The oral medication Orladeyo (berotralstat) is now approved in Peru as a prophylactic, or preventive, treatment to reduce the risk of swelling attacks in people with hereditary angioedema (HAE), ages 12 and older. The approval from Peru’s General Directorate of Medicines, Supplies and Drugs comes just months after…

Switching to Orladeyo (berotralstat) may help reduce the frequency and duration of swelling attacks in people with hereditary angioedema (HAE) who have normal levels and activity of a protein called C1-inhibitor, according to a European case series. These data add “clinically relevant evidence” to a growing body of…

Orladeyo (berotralstat), an oral therapy designed to prevent swelling attacks in adults and adolescents with hereditary angioedema (HAE), has now been approved in Mexico. The approval by the Mexican Federal Commission for Protection against Health Risks (COFEPRIS) covers the use of Orladeyo as a prophylactic, or preventive, treatment for HAE…

Treatment with oral Orladeyo (berotralstat) led to significantly fewer disease-related or all-cause hospitalizations and emergency room visits by people with hereditary angioedema (HAE) in the U.S., according to a real-world claims analysis. “The data presented here represent the first documentation that prescribing Orladeyo significantly reduces healthcare resource utilization,”…