AstraZeneca’s efzimfotase alfa wins FDA priority review for hypophosphatasia treatment in patients aged 2+ - AZN News | RalliesAstraZeneca’s efzimfotase alfa wins FDA priority review for hypophosphatasia treatment in patients aged 2+
A
AZN• FDA priority review granted for efzimfotase alfa
- AstraZeneca’s Alexion unit won FDA Priority Review for efzimfotase alfa to treat hypophosphatasia in patients aged 2 and older.
- The FDA action date is expected in the first half of 2027 under the PDUFA timeline.
- The filing is backed by Phase III results from the HICKORY, MULBERRY, and CHESTNUT trials.