NAIROBI, Kenya, Oct 19 – The Kenya Pharmacy and Poisons Board (PPB) has approved the registration as well as marketing authorization for Sacubitril/Valsartan to be used by adults in the treatment for symptomatic chronic heart failure with reduced ejection fraction.
Reduced ejection fraction is a condition where there is a less percentage of blood leaving the heart each time it contracts.
It is the first and only approved medicine of its kind, receiving top-class recommendation in the US and EU clinical guidelines for treatment of heart failure with reduced ejection fraction.
“Around half of people with heart failure will have reduced ejection fraction. The product offers a significant improvement in the safety and effectiveness of heart failure treatment versus current standard of care,” the President of the Kenya Cardiac Society Bernard Gitura said.
The oral treatment is designed to reduce the strain on a failing heart by enhancing the protective neuro-hormonal systems of the heart.
“The drug offers a significant improvement in the safety and effectiveness of heart failure treatment versus current standard of care as is evident in other countries where it is in use.”
The drug which is prescribed monthly is available countrywide in pharmacies and retails at between Sh7,000 to Sh9,000.
One will need a doctor’s prescription to be able to buy the drug.
Unlike in the West, the overwhelming cause of heart failure in Kenya is hypertension, followed by cardiomyopathy, rheumatic heart disease and ischemic heart disease.
Medics state that currently recommended treatments have improved the prognosis for people with heart failure.
“Excitement has been growing for the novel treatment since the results of the Paradigm HF trial were announced nearly two years ago showing a 20 per cent reduction in the risk of death from cardiovascular causes or hospitalization for worsening heart failure,” said Dr Gitura.
Heart failure specialist at the Aga Khan University Hospital Nairobi, Dr Anders Barasa, said that despite the growing treatment options for heart failure in recent years, management of this condition remains daunting for health care practitioners.
Heart specialists note that the newly approved Sacubitril/Valsartan drug will offer significant improvement in the safety and effectiveness of heart failure treatment versus current standard of care.
The trial also found that the drug reduced the number of patients who had to be hospitalized for heart failure.
Quick facts about heart failure are that it is fast approaching epidemic proportions, impacting more than 60 million people worldwide. It is the number one reason for hospitalization in people over 65 years.
Heart failure is a major and growing health-economic burden that currently costs the world economy $108 billion every year.
There is currently no cure for heart failure, leading to the death of around half of all patients within five years of diagnosis.