• Drug Coverage
  • Hypertrophic Cardiomyopathy (HCM)
  • Vaccines: 2023 Year in Review
  • Eyecare
  • Urothelial Carcinoma
  • Women's Health
  • Hemophilia
  • Heart Failure
  • Vaccines
  • Neonatal Care
  • NSCLC
  • Type II Inflammation
  • Substance Use Disorder
  • Gene Therapy
  • Lung Cancer
  • Spinal Muscular Atrophy
  • HIV
  • Post-Acute Care
  • Liver Disease
  • Pulmonary Arterial Hypertension
  • Safety & Recalls
  • Biologics
  • Asthma
  • Atrial Fibrillation
  • Type I Diabetes
  • RSV
  • COVID-19
  • Cardiovascular Diseases
  • Breast Cancer
  • Prescription Digital Therapeutics
  • Reproductive Health
  • The Improving Patient Access Podcast
  • Blood Cancer
  • Ulcerative Colitis
  • Respiratory Conditions
  • Multiple Sclerosis
  • Digital Health
  • Population Health
  • Sleep Disorders
  • Biosimilars
  • Plaque Psoriasis
  • Leukemia and Lymphoma
  • Oncology
  • Pediatrics
  • Urology
  • Obstetrics-Gynecology & Women's Health
  • Opioids
  • Solid Tumors
  • Autoimmune Diseases
  • Dermatology
  • Diabetes
  • Mental Health

FDA grants priority review to TB drug

News
Article

FDA has granted priority review to bedaquiline, or TMC207 (Johnson & Johnson's Janssen Research & Development), for treatment of multidrug-resistant tuberculosis.

FDA has granted priority review to bedaquiline, or TMC207 (Johnson & Johnson's Janssen Research & Development), for treatment of multidrug-resistant tuberculosis (TB). Bedaquiline would be the first drug specifically indicated for multidrug-resistant TB, and the first new type of TB drug in more than 4 decades.

On June 29, the drug maker applied for approval to market bedaquiline as part of combination therapy for adults with multidrug-resistant TB lung infections.

Under a priority review, FDA aims to decide whether to approve drugs within 6 months of the application's submission, rather than the standard 10 months.

About 1.4 million people worldwide die from TB each year, about 10% of them from forms resistant to at least 2 of the standard drugs for the deadly bacterial disease.

J&J applied for approval to market the drug in the European Union on Aug. 31.

Related Videos
Related Content
© 2024 MJH Life Sciences

All rights reserved.