trending Market Intelligence /marketintelligence/en/news-insights/trending/gam3vckg91uuhfm9k7a1ua2 content esgSubNav
In This List

EU grants conditional approval for Kyowa Hakko, Ultragenyx genetic disorder drug

Blog

A Pharmaceutical Company Capitalizes on M&A Activity with Brokerage Research

Blog

2021 Year in Review: Highlighting Key Investment Banking Trends

Blog

Insight Weekly: US stock performance; banks' M&A risk; COVID-19 vaccine makers' earnings

Blog

Global M&A By the Numbers: Q3 2021


EU grants conditional approval for Kyowa Hakko, Ultragenyx genetic disorder drug

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.