Thursday, March 23, 2023
News on Pathogens and Preparedness
Global Biodefense
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe
No Result
View All Result
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe
No Result
View All Result
Global Biodefense
No Result
View All Result
Home Industry News

J&J Tuberculosis Drug Submitted for FDA New Drug Application Approval

by Global Biodefense Staff
July 4, 2012

Johnson & Johnson’s Janssen Research & Development unit announced Monday that they have filed a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bedaquiline. If approved, the drug would be the first tuberculosis (TB) countermeasure in over 40 years with a new mechanism of action.

The Janssen TB drug targets adenosine triphosphate synthase, which Mycobacterium tuberculosis requires for generating its energy. Bedaquiline is seeking indications as an oral treatment to be used as part of combination therapy for pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults.  If approved, bedaquiline would also be the first medication intended for treating the resistant forms of TB.

Despite widespread use of an existing vaccine and the availability of several anti-TB drugs, the disease remains a major global health problem. In 2010, 8.8 million people fell ill with TB and 1.4 million died of the disease, according to the World Health Organization. Of those, an estimated 650,000 were cases of MDR-TB. The prevalence of resistant strains is on the rise, and is especially common in Africa and Asia.

A Phase III clinical trial comparing nine months of medication with bedaquiline in contrast with a placebo in about 600 patients is scheduled to begin at the end of 2012. The study will assess the new shorter treatment length of 9 months as compared the current 18 to 24 months recommended by the World Health Organization (WHO).

The company noted that this first filing in the U.S. will be followed by applications in other countries where TB is prevalent.

Tags: Tuberculosis

Related Posts

DARPA Selects Teams to Develop Vaccine Durability Prediction Model
Medical Countermeasures

DARPA Selects Teams to Develop Vaccine Durability Prediction Model

January 13, 2023
small glass vials on an assembly line await filling of vaccine solution
Industry News

Sabin Vaccine Institute to Advance Ebola Sudan and Marburg Vaccines with New BARDA Funding

January 12, 2023
How Are Bivalent COVID Vaccines Stacking Up Against Omicron?
Infectious Diseases

How Are Bivalent COVID Vaccines Stacking Up Against Omicron?

January 12, 2023
NISTCHO: New Living Reference Material for Producing Monoclonal Antibodies
Medical Countermeasures

NISTCHO: New Living Reference Material for Producing Monoclonal Antibodies

January 12, 2023
Load More

Latest News

Biodefense Headlines – 12 March 2023

Biodefense Headlines – 12 March 2023

March 12, 2023
Partner Therapeutics’ Novel Approach to Stratify Sepsis Patients Gains Backing From BARDA

Biopreparedness Research Virtual Environment (BRaVE) Initiative Backed by $105M DOE Funding

January 25, 2023
Influenza Proteins Tilt and Wave in ‘Breath-like’ Motions

Influenza Proteins Tilt and Wave in ‘Breath-like’ Motions

January 25, 2023
Biodefense Headlines – 24 January 2023

Biodefense Headlines – 24 January 2023

January 24, 2023

Subscribe

  • About
  • Contact
  • Privacy
  • Subscribe

© 2022 Stemar Media Group LLC

No Result
View All Result
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe

© 2022 Stemar Media Group LLC