Declan 2.0 schreef op 16 november 2018 14:04:
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Shire presents new late-stage data on HAE med lanadelumab
Nov. 16, 2018 7:03 AM ET|About: Shire PLC (SHPG)|By: Douglas W. House, SA News Editor
Shire plc (NASDAQ:SHPG) announces additional data from the Phase 3 HELP study evaluating subcutaneously administered TAKHZYRO (lanadelumab) for preventing hereditary angioedema (HAE) attacks. The results will be presented at the ACAII Annual Scientific Meeting in Seattle, WA.
The data showed that patients receiving 300 mg of lanadelumab every two weeks experienced significantly fewer HAE attacks, were less likely to have moderate or severe HAE attacks and were less likely to need rescue medication.
A long-term extension study is ongoing.
Lanadelumab is a monoclonal antibody the inhibits an enzyme called plasma kallikrein which plays a key role in HAE.
The FDA approved TAKHZYRO in August. The European Commission should OK it this quarter.
Ruud..