Kyowa Hakko Kirin Co. Ltd. said the European Commission granted conditional approval for Crysvita in treating a rare musculoskeletal disorder which is characterized by low phosphate levels in the blood.
Crysvita, or burosumab, is meant to treat X-linked hypophosphatemia, or XLH, in children that are at least 1 year old.
In December 2017, the European Commission's Committee for Medicinal Products for Human Use recommended the conditional approval of the drug based on positive data from clinical trials.
A conditional approval is usually granted when a medicine addresses unmet medical needs of patients on the basis of less comprehensive data than normally required.
The Tokyo-based life pharmaceutical company expects to commercially launch the treatment in Germany in the second quarter, followed by other European countries.
Kyowa Hakko and Ultragenyx Pharmaceutical Inc., a Novato, Calif.-based biopharmaceutical company, are collaborating in the development and commercialization of the drug.