Sanofi: new application for Praluent examined by FDA
(CercleFinance.com) - Sanofi and Regeneron have announced that the FDA in the US has agreed to consider the additional application for the licence of biological product (sBLA) for Praluent (alirocumab), a PCSK9 inhibitor solution in injectable form.
This request provides for the potential updating of product indications to include Praluent's effect on reducing the overall risk of major cardiovascular events. The FDA will announce its decision on 28 April 2019.
In addition, these pharmaceutical laboratories say that the FDA has recently approved the updating of the Praluent indications and their extension to certain patients treated with LDL-apheresis.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
This request provides for the potential updating of product indications to include Praluent's effect on reducing the overall risk of major cardiovascular events. The FDA will announce its decision on 28 April 2019.
In addition, these pharmaceutical laboratories say that the FDA has recently approved the updating of the Praluent indications and their extension to certain patients treated with LDL-apheresis.
Copyright (c) 2018 CercleFinance.com. All rights reserved.