Posted by Michael Wonder on 01 Jun 2020
Takeda receives positive CHMP opinion for pre-filled syringe presentation of Takhzyro (lanadelumab) for use as a preventive treatment for hereditary angioedema attacks
29 May 2020 - Validation of type II variation will allow Takeda to commence launches in Europe later this year.
Takeda today announced that the EMA CHMP has adopted a positive opinion on a type II variation regulatory application and recommended the approval of a pre-filled syringe presentation of Takhyzro (lanadelumab).
Takhzyro is a subcutaneous injectable prescription medication approved in Europe for routine prevention of recurrent attacks of hereditary angioedema in patients aged 12 years and older.
