Janssen’s Sirturo (bedaquiline) Receives FDA’s Accelerated Approval as a Combination Therapy to Treat Adolescents with Pulmonary Multidrug-Resistant Tuberculosis

 Janssen’s Sirturo (bedaquiline) Receives FDA’s Accelerated Approval as a Combination Therapy to Treat Adolescents with Pulmonary Multidrug-Resistant Tuberculosis

Janssen’s Sirturo (bedaquiline) Receives FDA’s Accelerated Approval as a Combination Therapy to Treat Adolescents with Pulmonary Multidrug-Resistant Tuberculosis

Shots:

  • The approval is based on P-II study results assessing Sirturo (400 mg first 2wks., 200 mg three times per week) in combination with a background regimen in 15 pediatric patients with confirmed or probable MDR-TB infection
  • The study resulted in conversion to a negative culture in 6/8 (75%) patients at Week 24 with no death occurrence and laboratory abnormalities were comparable to those in adults. The product is approved under FDA’s accelerated approval pathway based on time to sputum culture conversion for eligible MDR-TB patients aged 12 years  
  • Sirturo (bedaquiline) is a diarylquinoline antimycobacterial drug targeted as a combination therapy in adults and pediatric patients (12 to <18 years of age and weighing at least 30 kg) with pulmonary MDR-TB. Janssen has filed Sirturo’s approval to the EMA for adolescents with expected results in H2’19

Click here to­ read full press release/ article | Ref: Janssen Pharmaceutical | Image: Behance

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

Related post