Sanofi and Regeneron Announce FDA Approval of Praluent for High LDL Cholesterol Treatment

Strategic Insights -

Sanofi and Regeneron Pharmaceuticals have announced the approval of Praluent (alirocumab) Injection by the U.S. Food and Drug Administration (FDA) for the treatment of adults with high levels of low-density lipoprotein (LDL) cholesterol. Praluent is the first FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. This approval comes after a comprehensive evaluation of the pivotal Phase 3 ODYSSEY clinical trial program, which demonstrated the efficacy and safety of Praluent in reducing LDL cholesterol levels in patients with high LDL cholesterol.

Key Takeaways:

  • Praluent is the first FDA-approved treatment in a new class of drugs known as PCSK9 inhibitors, which work by blocking the PCSK9 protein to prevent the liver from absorbing LDL cholesterol.
  • Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL cholesterol.
  • The approval was based on data from the pivotal Phase 3 ODYSSEY program, which showed consistent, positive results compared to placebo and included current standard of care therapy (statins).
  • Praluent reduced LDL cholesterol by 58% versus placebo at week 24 in the ODYSSEY LONG TERM trial.
  • Praluent is generally well-tolerated with an acceptable safety profile, with local injection site reactions being the most common events.
  • Sanofi and Regeneron have committed to ensuring that patients in the U.S. who are prescribed Praluent are able to access the medicine and receive the support they may need.

Statistics:

  • Approximately 8-10 million patients in the U.S. face the challenge of achieving LDL cholesterol levels recommended by healthcare providers, despite treatment with standard of care including statins.
  • The U.S. Wholesale Acquisition Cost (WAC) price of Praluent is $40 per day ($1,120 every 28 days) for both the 75 mg and 150 mg doses.
  • The companies expect that actual costs to patients, payers, and health systems will be lower as WAC pricing does not reflect discounts or rebates.

Sources:

  • NewsRx, "Sanofi and Regeneron Announce FDA Approval of Praluent for High LDL Cholesterol Treatment"
  • [1] News Release, Sanofi and Regeneron, "Sanofi and Regeneron Announce FDA Approval of Praluent (alirocumab) Injection for the Treatment of High LDL Cholesterol in Adult Patients"