Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, has announced that it has acquired marketing approval for Revcovi 2.4 mg for intramuscular injection [Elapegademase (genetical recombination)] from the Ministry of Health, Labor and Welfare (MHLW) .

Teijin Pharma has exclusive development and marketing rights in Japan to Revcovi, which was developed by Leadiant Biosciences Limited, a UK-based pharmaceuticals company. Revcovi was designated as an orphan drug by MHLW in March 2016.

In a Phase III trial conducted by Teijin Pharma in Japan and a Phase III trial conducted by Leadiant Biosciences, Inc. in the United States, Revcovi injection increased Adenosine deaminase (ADA) activity and suggested improvement in immune function. Based on these trials, Teijin Pharma submitted its application in June 2018 and has now acquired marketing approval.

Adenosine deaminase (ADA) deficiency, an ultra-rare disease caused by a lack of ADA activity due to gene mutations, leads to lymphocyte reduction and severe combined immunodeficiency.

Revcovi 2.4 mg for intramuscular injection is Japan’s first drug for ADA enzyme replacement therapy. It is a recombinant adenosine deaminase analogue chemically modified with polyethylene glycol.