New Hope for Heart Failure Patients: Amgen's Corlanor Receives FDA Approval

Strategic Insights -

Pioneering a breakthrough in the treatment of chronic heart failure, the US FDA has approved Amgen's novel drug, Corlanor, providing a much-needed new option for millions of Americans and international patients suffering from this debilitating disease. As the global prevalence of heart failure increases, with over 25 million people worldwide affected, the FDA's approval of Corlanor offers new hope for those whose quality of life has been severely impacted by the condition.

Key Takeaways:

  • Corlanor is the first medication in 12 years to be approved for the treatment of heart failure, a condition that affects over 5 million Americans and 25 million people worldwide.
  • The drug has been shown to significantly reduce hospitalizations and deaths from heart failure, with a 25% reduction in both hospital admissions and deaths in patient trials.
  • Corlanor works by reducing heart rate in patients with low ejection fraction, a common symptom of heart failure, where the heart's main pumping chamber cannot push out enough blood.
  • The FDA has noted that women taking Corlanor should not become pregnant due to the risk of harm to the fetus.
  • Amgen's Corlanor has been sold in Europe under a different name since 2005 for angina, and since 2012 for heart failure, with Amgen acquiring the rights to US sales in a deal with the French developer, Les Laboratoires Servier.
  • The list price of Corlanor will be $375 per month without insurance, with Novartis's competing heart failure pill, LCZ696, yet to have its price set.

Statistics:

  • Over 5 million Americans and 25 million people worldwide suffer from heart failure, with the condition killing up to half of patients within five years.
  • Heart failure costs the global economy an estimated $108 billion annually.
  • Patients with heart failure are often hospitalized two to 12 times per year due to the condition.
  • Corlanor reduced hospital admissions and deaths from heart failure by about 25% in patient trials.
  • The Novartis drug, LCZ696, reduced hospitalizations for heart failure and death from heart disease about 20% more than enalapril in patient trials.

Sources:

  • U.S. FDA
  • Amgen Inc.
  • UBS Securities biotech analyst Matthew Roden