Sanofi: CHMP recommends approval of Praluent
(CercleFinance.com) - Sanofi announces that the CHMP of the European Medicines Agency has adopted a positive opinion for Praluent (alirocumab) for the reduction of cardiovascular risk in people with established atherosclerotic cardiovascular disease.
"Praluent should be used in addition to a maximally tolerated dose of statin or can be used alone in patients intolerant to or inappropriate for statin therapy," said the French pharmaceutical giant.
The European Commission is set to announce its final decision in the coming months. The CHMP's opinion is based on data from the Odyssey Outcomes phase III trial, which were also submitted to the US FDA, with a decision scheduled for 28 April.
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"Praluent should be used in addition to a maximally tolerated dose of statin or can be used alone in patients intolerant to or inappropriate for statin therapy," said the French pharmaceutical giant.
The European Commission is set to announce its final decision in the coming months. The CHMP's opinion is based on data from the Odyssey Outcomes phase III trial, which were also submitted to the US FDA, with a decision scheduled for 28 April.
Copyright (c) 2019 CercleFinance.com. All rights reserved.