Janssen forwards bedaquiline application to FDA

Janssen Research and Development has forwarded a new drug application to the US Food and Drug Administration (FDA) in a bid to gain approval for the investigational drug bedaquiline.

The clinical research specialist is hoping for the medicine to be used as an oral treatment as part of combination therapy for pulmonary, multi-drug resistant tuberculosis (MDR-TB).

If the drug is consented, it will be the first to have a new mechanism of action for TB in over 40 years, while existing as the only substance designated for MDR-TB.

Paul Stoffels, worldwide chairman of pharmaceuticals at Johnson & Johnson, which owns Jannsen, said: "The emergence of multi-drug resistant strains of TB is a growing problem that impacts people around the world and is posing a significant new treatment challenge in controlling this serious and deadly disease."

Janssen's application comes after it submitted a marketing authorisation application to the European Medicines Agency for the use of canagliflozin.

It is hoped that the medicine will act as effective treatment for adults with type 2 diabetes.

Go Back

Red Hot Jobs

Regional CRA Manager-Ophth...
Permanent Job
Executive/Officer
Clinical SOP Editor/ Admin...
Temporary Contract
Executive/Officer
Regional CRA Seast 12 Mon...
Temporary Contract
Executive/Officer
Clinical Research Scientis...
Temporary Contract
Senior Executive/Team Lead...
Safety Compliance Coordina...
Temporary Contract
Assistant/Associate
Study Manager I, Regional...
Temporary Contract
Executive/Officer
Website by: ioca Systems

Cookie Notice: Our website uses cookies for reasons explained in our Privacy Policy. You can disable cookies for this website using settings in your browser but parts of the site may not function correctly. By closing this message or by continuing to use this website, you consent to our use of cookies on this device unless you have disabled them.