On Tuesday, the FDA approved a revolutionary heart failure drug, Entresto, half of year before time. The new drug can lower mortality rate and hospital visits linked to heart failure by up to 20 percent.
The current standard medication in heart failure is Enalapril.
Dr. Sean Pinney, heart failure specialist from The Mount Sinai Hospital in New York City, recently told reporters that he and his colleagues had been waiting for a drug like Entresto to be approved for 15 years.
“It reduces heart failure hospitalizations and it helps people with heart failure live longer–and it’s powerful,”
noted Dr. Pinney.
But the FDA approves only drugs that meet certain conditions before schedule. Those drugs must be the only medications that can treat life-threatening conditions, and a fast track approval would prevent the loss of human lives.
Entresto, scientifically dubbed LCZ696, didn’t undergo the review process because it met the conditions for fast-track approval.
Moreover, the drug company presented the largest trial documenting the efficacy of a heart failure drug to date. About 8,400 patients were given either Entresto or the standard treatment Enalapril.
While on standard medication, 26.5 percent of heart failure patients were either hospitalized or died of the disease. But only 21.8 percent of those taking Entresto died or took a trip to the hospital. The new drug is entirely different from standard drugs. It mixes the drug maker’s high blood pressure drug with another drug that can inhibit a harmful enzyme which plays a key role in heart failure.
Dr. Milton Packer, senior researcher involved in the study and professor from the University of Texas Southwestern Medical Center’s Department of Clinical Sciences, said that the new heart failure drug displayed a “very meaningful survival advantage.”
Additionally, the new therapy does not have more side-effects than current medications have. It can significantly lower blood pressure, hike potassium levels, and meddle with kidneys.
But these side-effects usually affect African-Americans and those who cannot put up with low blood pressure and may fall or experience dizziness. African-Americans, Dr Pinney explained, are more prone to angioedema, a condition that results in tongue and lip swelling.
The new drug may indeed be crucial in treating heart failure. The CDC reported that one in nine deaths in the U.S. is linked to heart failure. In addition, if one gets diagnosed with the diseases he or she has a life expectancy of only five years on average and the patient needs to take drugs for the rest of their lives.
Image Source: European Pharmaceutical Review