New Drug May Prove to Help Millions with High Blood Pressure

Strategic Insights -

A new drug, VANLEV, is being fast-tracked by the US FDA for approval to treat high blood pressure, a condition that affects over 50 million Americans. This novel cardiovascular compound, discovered by Bristol-Myers Squibb researchers, targets a new class of enzymes that regulate blood pressure. The FDA has indicated that it will make a decision on the drug's approvability by June 20, 2000, marking the first time an antihypertensive has received priority review under the Prescription Drug User Fee Act.

Key Takeaways:

  • VANLEV is a single molecule designed to inhibit two key enzymes, neutral endopeptidase (NEP) and angiotensin-converting enzyme (ACE), which regulate blood pressure.
  • The drug has undergone an extensive clinical development program involving 16 controlled trials in over 6900 patients with all stages of hypertension, with some patients treated for up to two years.
  • The most commonly reported side effects in placebo-controlled trials were headache, dizziness, upper respiratory tract infection, and cough, which were more common in the placebo group.
  • VANLEV has shown promise in treating systolic blood pressure, which is a significant predictor of cardiovascular risk.
  • The FDA's priority review is a significant development for VANLEV, as it indicates that the agency believes the drug has the potential to provide a significant therapeutic advance.
  • Bristol-Myers Squibb's Chairman and CEO, Charles A. Heimbold, expressed enthusiasm for the priority review, stating that the company looks forward to working with the FDA to bring VANLEV to market.

Statistics:

  • Over 50 million Americans suffer from high blood pressure.
  • Only one in four people with high blood pressure in the US is treated to the recommended goal of 140/90mmHg.
  • The FDA has expedited priority review for VANLEV, with a goal of ruling on the drug's approvability by June 20, 2000.
  • The VANLEV NDA filing is based on an extensive clinical development program involving 16 controlled trials in over 6900 patients.

Sources:

  • "Bristol Myers-Squibb Company Announces FDA Priority Review for VANLEV" (PRNewswire, Jan. 10)
  • Bristol-Myers Squibb Company (BMY) (NYSE)
  • FDA (U.S. Food and Drug Administration)
  • Prescription Drug User Fee Act
  • Charles A. Heimbold, Chairman and CEO, Bristol-Myers Squibb Company