Israel Agrees to Review BioCryst’s Marketing Request for Orladeyo

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by Patricia Inacio PhD |

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Orladeyo 

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, if it’s approved. This follows a distribution and supply agreement granting Neopharm Ltd. the exclusive rights to commercialize the therapy in Israel and in the Palestinian Authority.

“Neopharm is the right partner to help us commercialize in Israel as we continue to bring oral, once-daily Orladeyo to HAE patients around the world,” Charlie Gayer, chief commercial officer of BioCryst, said in a press release. “They have extensive rare disease experience and proven commercial success in Israel, and they understand the local regulatory environment.”

Orladeyo works by suppressing the production of bradykinin, an inflammatory molecule overly produced in HAE patients. When present in excess, bradykinin causes blood vessels to widen and become leaky, resulting in fluid buildup in surrounding tissues. That, in turn, leads to swelling, a typical feature of HAE attacks.

The therapy has been approved in the U.S., European Union, and U.K., and in Japan for similar indications.

Orladeyo’s approvals were supported by data from two ongoing trials: the placebo-controlled Phase 3 APeX-2 trial (NCT03485911) and the open-label Phase 2/3 APeX-S trial (NCT03472040), which are evaluating the safety and effectiveness of the medication at preventing HAE attacks in patients 12 and older.

Data from these studies showed that Orladeyo was effective at lowering the rate of monthly HAE attacks, as well as the need for standard-of-care treatment. Orladeyo treatment was also associated with improvements in quality of life.

The therapy was considered generally safe and well-tolerated. Gastrointestinal issues were the most common adverse events observed. However, these occurred early on in the treatment course, and their frequency decreased over time.

“We are proud of our partnership with BioCryst and excited to deliver a new and innovative treatment option to HAE patients in Israel,” said Efi Shnaidman, general manager of Neopharm Israel. “The momentum gained from recent approvals of Orladeyo across the globe will support our commercialization efforts to provide access to this important treatment.”