Posted by Michael Wonder on 19 Apr 2018
Swissmedic validates Shire’s marketing authorisation application for investigational hereditary angioedema treatment lanadelumab
18 April 2018 - Swissmedic validation shows continued regulatory progress for lanadelumab.
Shire announced today that the Swiss Agency for Therapeutic Products (Swissmedic) has validated the marketing authorisation application for lanadelumab (SHP643). The validation of the application confirms that the lanadelumab submission is complete and that the formal review process will begin.
Lanadelumab is an investigational treatment being evaluated for the prevention of angioedema attacks in patients 12 years and older with hereditary angioedema. Lanadelumab was also designated orphan drug status by Swissmedic.
