FDA approval for prefilled syringe presentation of Takhzyro for use as a preventive treatment for hereditary angioedema attacks.- Takeda
Takeda announced the FDA approval of the Takhzyro (lanadelumab-flyo) injection single-dose prefilled syringe (PFS) to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older.
The PFS is ready to use and requires fewer preparation steps than the current TAKHZYRO vial injection, while also reducing supplies and waste.
"This announcement is an important innovation for Takhzyro offering people living with HAE and their caregivers an enhanced treatment administration experience with proven sustained reduction of attacks,” said Cheryl Schwartz, Senior Vice President, Rare Disease Business Unit at Takeda Pharmaceutical Company Limited. “This product delivery enhancement is intended to improve the overall patient experience and reflects Takeda’s continued commitment to the HAE community; we look forward to introducing this new option to patients later this year.”.