Sanofi and Regeneron's Praluent Meets Primary Endpoint in Phase 3 Trial

Strategic Insights -

Japanese patients with hypercholesterolemia at high cardiovascular risk, or with an inherited form of high cholesterol, benefited significantly from the investigational therapy Praluent, as part of its standard of care, including statins. The trial, ODYSSEY JAPAN, demonstrated a substantial reduction in low-density lipoprotein cholesterol (LDL-C) levels in the patients. Praluent, a fully human monoclonal antibody, targets PCSK9 and has shown promise in addressing unmet needs in Japan, particularly among those with pre-existing cardiovascular disease or a history of heart attack.

Key Takeaways:

  • The Phase 3 ODYSSEY JAPAN trial met its primary endpoint, demonstrating a 64 percent greater reduction in LDL-C levels from baseline when Praluent was added to standard care, compared to standard care alone.
  • The trial involved 216 Japanese patients with hypercholesterolemia at high cardiovascular risk and/or with an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH).
  • Ninety-nine percent of patients who received Praluent at week 12 remained on the initial 75 mg dose, while one percent had their dose adjusted to 150 mg every two weeks.
  • The most common adverse events in the Praluent group were nasopharyngitis, injection site reaction, and back pain.
  • Praluent is an investigational therapy targeting PCSK9, aiming to address unmet needs in Japan, particularly among those with pre-existing cardiovascular disease or a history of heart attack.
  • The safety and efficacy of Praluent have not been fully evaluated by any regulatory authority.
  • The Marketing Authorization Application for Praluent in the European Union is currently under review by the European Medicines Agency (EMA).

Statistics:

  • 216 patients were enrolled in the ODYSSEY JAPAN trial.
  • 144 patients received Praluent, while 72 received placebo.
  • The mean LDL-C value at baseline was 141.2 mg/dL.
  • At week 24, patients in the Praluent group experienced a 64 percent greater reduction from baseline in their LDL-C levels (p < 0.0001).
  • Ninety-nine percent of patients remained on the initial 75 mg dose, while one percent had their dose adjusted.

Sources:

  • Sanofi
  • Regeneron Pharmaceuticals, Inc.