Regeneron and Sanofi Announces Acceptance of sBLA for PRALUENT’s by the US for the Treatment of Reduction in MACE

 Regeneron and Sanofi Announces Acceptance of sBLA for PRALUENT’s by the US for the Treatment of Reduction in MACE

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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Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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