Regulatory health agencies in Canada and Switzerland have approved BioCryst Pharmaceuticals’ Orladeyo (berotralstat) as the first daily oral therapy to prevent hereditary angioedema (HAE) attacks. With these approvals, Orladeyo will be available in the two countries for the routine prevention of HAE attacks in patients ages 12 and…

Orladeyo (berotralstat) reduced the frequency of swelling attacks in people with hereditary angioedema (HAE) and improved their quality of life over the course of one year, according to the latest findings from the long-term APeX-S trial. The approved oral medication also was able to sustainably lower HAE attack…

The United Arab Emirates (UAE) has approved BioCryst Pharmaceuticals’ Orladeyo (berotralstat) for preventing hereditary angioedema (HAE) attacks in patients, 12 and older. “As the first targeted oral, once-daily treatment, Orladeyo provides an important new treatment option for patients and physicians,” Henrik Balle Boysen, executive vice president and chief operating…

Regulatory health agencies in Canada and Switzerland are reviewing BioCryst Pharmaceuticals’ applications for the approval of Orladeyo (berotralstat) in their countries for preventing hereditary angioedema (HAE) attacks in patients ages 12 and older. The applications — to Heath Canada and Swissmedic — followed Orladeyo’s recent approvals in the…

Treatment with Orladeyo (berotralstat) was generally safe and well-tolerated in people with hereditary angioedema (HAE), according to recently released trial data. The findings from an interim analysis of the open-label APeX-S trial also supported Orladeyo’s ability to reduce the frequency of HAE attacks, ease symptom burden, and improve…

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing approval to BioCryst Pharmaceuticals’ Orladeyo (berotralstat), as the first oral and daily therapy to prevent acute attacks of hereditary angioedema (HAE) in individuals ages 12 and older. “HAE UK welcomes the decision from the MHRA…

The European Commission has approved BioCryst Pharmaceuticals’ Orladeyo (berotralstat) as the first oral, daily therapy to prevent swelling attacks in adults and adolescents, ages 12 and older, with hereditary angioedema (HAE). An oral preventive therapy should be easier to take than standard under-the-skin and into-the-vein alternatives, and as…

Preventive treatment with oral berotralstat (BCX7353) significantly lowers the frequency of swelling attacks in people with hereditary angioedema (HAE), newly published results from the APeX-2 clinical trial demonstrate. The study, “Oral once-daily berotralstat for the prevention of hereditary angioedema attacks: a randomized, double-blind, placebo-controlled phase 3…

BioCryst Pharmaceuticals is prepared to launch Orladeyo (berotralstat), an oral treatment for hereditary angioedema (HAE), by the end of the year if the medication is approved, the company has announced. “We are currently in an exciting transformation from a company primarily focused on R&D [research and development]…

New clinical trial data show that BioCryst Pharmaceuticals‘ investigational therapy for hereditary angioedema (HAE), berotralstat, reduces the frequency of HAE attacks and improves patients’ quality of life through 48 weeks of treatment. The data were presented at the European Academy of Allergy and Clinical Immunology Digital Congress. HAE…