Rare disease candidate burosumab given priority review status by US FDA

Nasdaq-listed Ultragenyx Pharmaceutical and Japan’s Kyowa Kirin have announced the US FDA will review burosumab as a treatment for pediatric and adult patients with X-linked hypophosphatemia (XLH).

The regulatory filing has furthermore been granted priority review status, with a decision expected by April 17 next year.

The candidate was previously given breakthrough therapy designation in this indication.