Takeda’s Takhzyro sBLA Gains Priority Review

The FDA has granted a priority review to Takeda’s supplemental Biologics License Application (sBLA) for Takhzyro (lanadelumab-flyo) for prevention of attacks of hereditary edema in children under 12 years old.

Hereditary angioedema is a rare genetic disorder that results in recurring attacks of edema or swelling in various parts of the body.

Currently, the drug is FDA-approved to prevent attacks of hereditary angioedema in people 12 years of age and older. The sBLA would expand the indicated usage to include pediatric patients who are between two and 12 years old.

The FDA is expected to decide on this sBLA in the first half of 2023.