Announcement of listing on the NHI drug price standard and marketing of Empaveli® Subcutaneous Injection 1080 mg in Japan
August 30, 2023
Asahi Kasei Pharma Corp.
Asahi Kasei Pharma announces that Empaveli® Subcutaneous Injection 1080 mg (generic name: pegcetacoplan), a complement protein C3 inhibitor, for which it obtained exclusive distribution rights in Japan from Swedish Orphan Biovitrum Japan Co., Ltd. (Sobi Japan), has been listed on Japan’s National Health Insurance (NHI) drug price standard today. The launch of the product is scheduled for September 4, 2023.
Pegcetacoplan is a PEGylated peptide1 inhibiting the function of complement protein C3, which is involved in hemolysis (breaking down of red blood cells), and has been approved as a therapeutic drug for paroxysmal nocturnal hemoglobinuria (PNH)2 in the U.S. and Europe. It is sold as Empaveli® in the U.S. by Apellis Pharmaceuticals, Inc., and as Aspaveli® in Europe by Swedish Orphan Biovitrum AB (Sobi), the parent company of Sobi Japan.
By providing a new therapeutic option for patients with PNH, Asahi Kasei Pharma aims to realize a society where “no one should have to give up doing what they love due to illness” in accordance with its mission “to sincerely care for each individual life and solve their unmet medical needs with a wealth of ideas and solid science.”
Product overview of Empaveli® Subcutaneous Injection 1080 mg
- Product name
- Empaveli® Subcutaneous Injection 1080 mg
- Generic name
- Pegcetacoplan
- Indication
- Paroxysmal nocturnal hemoglobinuria
- Dosage and administration
- For adults, ordinarily administer 1,080 mg of pegcetacoplan by subcutaneous injection twice per week. For patients with inadequate clinical response, 1,080 mg may be administered by subcutaneous injection once every 3 days.
- Manufacture
- Swedish Orphan Biovitrum Japan Co., Ltd.
- Sale
- Asahi Kasei Pharma Corporation
- Approval
- March 27, 2023
- NHI price listing
- August 30, 2023
- Launch of sale
- September 4, 2023
- NHI price
- ¥488,121
About Swedish Orphan Biovitrum AB
Founded in 2009, Sobi is a specialized international biopharmaceutical company headquartered in Stockholm, Sweden, transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,600 employees across Europe, North America, the Middle East, Asia and Australia. To learn more, visit https://www.sobi.com/
- 1A PEGylated peptide is a peptide which has been chemically modified by the attachment of polyethylene glycol (PEG) chains. Such modification is expected to extend the half-life of the peptide in blood.
- 2PNH is a rare, chronic, late-onset, and potentially life-threatening hematological disorder characterized by an increased risk of debilitating hemolytic anemia, bone marrow failure, and thrombosis through the protein complement system. A continually low level of hemoglobin causes anemia, severe fatigue, and dependency on blood transfusions. According to statistical data from the Ministry of Health, Labour and Welfare, there were 927 PNH patients in Japan in 2020.