Orladeyo is a small molecule designed to suppress the activity of plasma kallikrein, a precursor of bradykinin — an inflammatory molecule produced in excess in Hereditary Angioedema (HAE) patients, leading to sudden and recurrent bouts of swelling. By suppressing plasma kallikrein, the medication is expected to lower bradykinin levels and prevent angioedema attacks.
Approved in early December 2020 in the U.S., Orladeyo is the first and only oral treatment to prevent swelling attacks in HAE patients, ages 12 and older. Similar applications are being reviewed in Japan and in the European Union, with a decision expected this month in Japan; a decision in the EU is anticipated in March 2021.
BioCryst believes ORLADEYO has the potential to generate more than $500 million in global peak sales. The company invested early to be ready for a fast launch to get patients on therapy quickly and to secure reimbursement access for ORLADEYO.
According to BioCryst Pharmaceuticals (BioCryst), the maker of Orladeyo, the medicine will be provided exclusively by specialty pharmacy Optime Care, which has already begun shipping to patients.
BioCryst is committed to supporting HAE patients taking Orladeyo through a new program designed to streamline access to therapy. Through EMPOWER Patient Services, each HAE patient and their healthcare provider will have a single point of contact for access to Orladeyo. A dedicated care coordinator will support access for each patient with comprehensive financial support tools and reimbursement support. EMPOWER Patients Services is administered by Optime Care Inc.
Optime Care is a nationally recognized pharmacy, distribution, and patient management organization, that brings to the market a suite of comprehensive services tailored to maximize the therapeutic opportunities for the treatment of orphan and rare disorders. The company accomplishes this by supporting patients, physicians, and bio-pharma partners in navigating the ever-changing healthcare environment.
Optime Care creates partnerships for personalized care with a specific focus on disorders affecting smaller patient communities. The team of experts in rare disorders works with healthcare providers, payers, biopharmaceutical companies, and patients to implement therapies and support services quickly.
The management team has previously partnered in the launch of more than 25 orphan products and consistently implemented the best brand program for the community. Optime Care has dual-accreditation from URAC for compliance with specialty pharmacy and ACHC for specialty pharmacy services.
Takeaway: Orladeyo’s approval makes it the first and only oral treatment for HAE patients