May. 29, 2019
(News Release) Teijin Pharma Launches Revcovi®, Japan’s First Drug for ADA Deficiency
Teijin Pharma Limited
Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, announced today that it has launched Revcovi® 2.4 mg for intramuscular injection [Elapegademase (Genetical Recombination)], effective immediately. Revcovi® 2.4 mg, Japan’s first drug for Adenosine deaminase (ADA) deficiency, is an enzyme replacement therapy that is expected to improve ADA activity and the immune system of ADA-deficiency patients.
ADA, an ultra-rare disease caused by a lack of ADA activity due to gene mutations, leads to infections and impaired growth resulting from severe combined immunodeficiency. The first-line treatment option for ADA deficiency is hematopoietic stem cell transplantation, and other options include administration of ADA for enzyme replacement therapy to improve immune functions.
Teijin Pharma concluded an exclusive development and marketing agreement with Leadiant Biosciences Limited (formerly known as Sigma-Tau Pharma Ltd.) in 2014, back when no drug for ADA enzyme replacement therapy had been approved. Marketing approval for the indication of ADA deficiency was received from Japan’s Ministry of Health, Labor and Welfare (MHLW) this past March.
Going forward, Teijin Pharma will market Revcovi® 2.4 mg to contribute to the quality of life of ADA-deficiency patients.
Revcovi® is a registered trademark of Leadiant Biosciences Limited.
|Brand name||Revcovi®2.4 mg for intramuscular injection|
|Nonproprietary name||Elapegademase (Genetical Recombination)|
|Dosage form||Aqueous injection (vial)|
|Indication||Adenosine Deaminase Deficiency|
|Dosage and Administration||
The usual intramuscular dose of Revcovi® 2.4 mg for Intramuscular injection is Elapegademase (Genetical Recombination) 0.2 mg/kg of body weight per dose given once a week. The dose should be increased or decreased depending on the patient’s conditions. The maximum dose per dose is 0.3 mg/kg. However, if it is necessary to promptly increase the adenosine deaminase activity, it can be injected intramuscularly twice a week at 0.2 mg/kg per dose.
|Standards||2.4 mg/1.5 mL per vial|
About Leadiant Biosciences Limited
Leadiant Biosciences Ltd., based in the United Kingdom, is the European arm of Leadiant Biosciences S.p.A. Formerly known as Sigma-Tau Rare Disease, Leadiant Biosciences is a research-based global pharmaceutical company that dedicates considerable resources to the development, registration and commercialization of novel and effective therapies that address patient needs and improve quality of life.
About the Teijin Group
Teijin (TSE: 3401) is a technology-driven global group offering advanced solutions in the areas of environmental value; safety, security and disaster mitigation; and demographic change and increased health consciousness. Its main fields of operation are high-performance fibers such as aramid, carbon fibers & composites, healthcare, films, resin & plastic processing, polyester fibers, products converting and IT. The group has over 170 companies and around 20,000 employees spread out over 20 countries worldwide. It posted consolidated sales of JPY888.6 billion (USD 8.1 billion) and total assets of JPY 1020.7 billion (USD 9.3 billion) in the fiscal year ending March 31, 2019. Please visit www.teijin.com
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