Regeneron and Sanofi Announces Acceptance of sBLA for PRALUENT's by the US for the Treatment of Reduction in MACE
Shots:
- Results of P-III ODYSSEY OUTCOMES assessing PRALUENT(alirocumab) IV (N= 18-924)- having an acute coronary syndrome (ACS)- such as a heart attack- b/w 1-12 mos before being enrolled
- The US FDA has set a PDUFA date of 28 April- 2019. ODYSSEY OUTCOMES demonstrated a reduction in overall risk of MACE
- Additionally- FDA updated Praluent PI for the treatment of heterozygous familial hypercholesterolemia (HeFH) in patients with recommended dose of 150 mg q2w
- Praluent (a PCSK9i) was developed by Regeneron and Sanofi using Regeneron’s VelocImmune technology- and is being approved in >60 countries (incl. the US- Japan- Canada- Switzerland- Mexico and Brazil and EU)
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