Regulatory authorities in Saudi Arabia have approved daily Orladeyo (berotralstat) to prevent hereditary angioedema (HAE) attacks in adult and adolescent patients, ages 12 and older. “There is a significant need for new treatment options for HAE in Saudi Arabia,” Charlie Gayer, chief commercial officer of BioCryst Pharmaceuticals,…

Switching from under-the-skin injections of Takhzyro (lanadelumab) to oral capsules of Orladeyo (berotralstat) was generally safe and kept the occurrence of swelling attacks at low rates over one year in people with hereditary angioedema (HAE), according to a new data analysis of the Phase 2/3 APeX-S trial.

Long-term treatment with Orladeyo (berotralstat) at its approved 150 mg daily dose reduces the rate of swelling attacks significantly and improves quality of life for people with hereditary angioedema (HAE), according to nearly two years of data from the Phase 3 APeX-2 trial. These benefits were observed to…

Orladeyo (berotralstat), an approved therapy for preventing swelling attacks in hereditary angiodema (HAE), was effective at controlling attacks in an HAE patient with normal C1 inhibitor activity, a case study reported. The clinician said this oral therapy may be particularly suitable for patients who have a needle phobia…

BioCryst Pharmaceuticals has received funds worth $350 million that will be used in part to support the global launch of Orladeyo (berotralstat), an oral therapy to prevent hereditary angioedema (HAE) swelling attacks. The money came through various transactions with Royalty Pharma, a global buyer of pharmaceutical royalties, 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…

Orladeyo (berotralstat), a daily oral therapy to prevent swelling attacks in people with hereditary angioedema (HAE), is now available in England, Wales, and Northern Ireland for eligible patients ages 12 and older. That authorization came as the U.K.’s National Institute for Health and Care Excellence (NICE) recommended Orladeyo —…

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 Israeli Ministry of Health has agreed to review, under an accelerated process, a marketing application for Orladeyo (berotralstat), BioCryst Pharmaceuticals’ oral preventive treatment for hereditary angioedema (HAE) attacks, in patients 12 and older. Neopharm Israel, one of the leading pharmaceutical companies in Israel, will distribute Orladeyo,…