Praluent Demonstrates Significant Cholesterol-Lowering Ability in Japanese Patients with Hypercholesterolemia

Strategic Insights -

At the Japanese Atherosclerosis Society (JAS) Annual Scientific Meeting, Regeneron Pharmaceuticals and Sanofi announced that the Phase 3 ODYSSEY JAPAN trial of the investigational therapy Praluent (alirocumab) met its primary endpoint. The trial evaluated the efficacy and safety of Praluent in Japanese patients with hypercholesterolemia at high cardiovascular (CV) risk and/or with an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH).

Key Takeaways:

  • The primary endpoint of the ODYSSEY JAPAN trial was met, with patients in the Praluent group experiencing an average 64 percent greater reduction from baseline in their bad cholesterol (LDL-C) at week 24 compared to standard of care alone (p less than 0.0001).
  • Ninety-seven percent of patients in the Praluent group reached their LDL-C treatment goal, compared to 10 percent for placebo (p less than 0.0001) at week 24.
  • Ninety-nine percent of patients treated with Praluent remained on the lower dose of 75 mg, while only two patients required adjustment to the higher dose of 150 mg.
  • The most common adverse events in the Praluent group were nasopharyngitis, injection site reaction, and back pain.
  • The safety and efficacy of Praluent have not been fully evaluated by any regulatory authority, and regulatory approval is pending in the United States and the European Union.

Statistics:

  • 99% of patients in the Praluent group remained on the lower dose of 75 mg at week 24.
  • 97% of patients in the Praluent group reached their LDL-C treatment goal at week 24.
  • The average LDL-C reduction for patients in the Praluent group was 64% at week 24.
  • The odds of reaching the LDL-C treatment goal were 9.7 times higher for patients in the Praluent group compared to the placebo group.
  • 10% of patients in the placebo group reached their LDL-C treatment goal at week 24.

Sources:

  • Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
  • Sanofi (EURONEXT: SAN)
  • Japanese Atherosclerosis Society (JAS)
  • U.S. Food and Drug Administration (FDA)
  • European Medicines Agency (EMA)
  • Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC)
  • Teikyo Academic Research Center