Shire: CHMP Recommends EU Marketing Authorisation Of Lanadelumab

(RTTNews) - Shire plc (SHP.L, SHPG) announced the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of marketing authorisation of lanadelumab injection for routine prevention of recurrent attacks of hereditary angioedema in patients aged 12 years and older. Lanadelumab was previously granted accelerated assessment by the EMA, reducing the number of evaluation days required from 210 to 150.

Lanadelumab received approval for the prevention of HAE attacks in patient 12 years and older in the U.S. on 23 August 2018 and Canada on 19 September 2018, under the brand name TAKHZYRO.