NEW BRUNSWICK, NJ—Johnson & Johnson announced last Monday that they are seeking approval of the Food & Drug Administration to sell bedaquiline, an expermiental drug that combats tuberculosis (TB).
Bedaquiline is the first drug specifically made to fight tuberculosis in over four decades. It was desinged to combat multidrug-resistant tuberculosis, according to a report on MyCentralJersey.com.
The Janssen Research & Development unit of Johnson & Johnson, creators of bedaquiline, tested the drug on hundreds of patients who have multidrug-resistant tuberculosis. Two of the mid-stage studies lasted for six months and some patients were studied for about 1½ years.
This fall, the company hopes to begin late-stage testing of the drug and will compare bedaquiline to placebos over the next nine months in about six hundred patients.
Each patient will take six other standard drugs that treated TB. This study aims to discover whether treatment for resistant TB will be reduced to nine months from the current eighteen to twenty four, recommended by the World Health Organization.
Considering, that TB is caused by a bacterial infection of the lungs and manifests in other parts of the body, TB is the No. 2 infectious disease that causes death in adults.
It is estimated that one-third of the world's population is infected with TB. The disease remains latent in most people for many years, but can be activated when the body is infected by another contagion.
Fortunately, TB is rare in the United States, however it is still considered a deadly virus on a global scale. It kills an estimated 1.4 million people a year and 150,000 of the deaths are due to the increasingly common multidrug-resistant form of TB, accroding to the report.
Dr. Wim Pays, Janssen’s head of infectious diseases, stated that "company also will apply for approval of bedaquiline in other countries where TB is very common.".
This is essential because TB is considered a major problem in developing countries, due to the long periods of time it takes to cure and because many patients stop taking their pills once they begin to feel better, though the bacteria is still alive in their system.