U.S. FDA Approves New Pediatric Formulation of SIRTURO (Bedaquiline) for Multidrug-Resistant Tuberculosis in Children Aged 5 and Older

May 29, 2020 /Bio ValleyBIOON/ -- Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), recently announced that the U.S. Food and Drug Administration (FDA) A new pediatric formulation of Sirturo® (bedaquiline) has been approved, and the drug is now used as part of combination regimens for the treatment of multidrug-resistant tuberculosis (MDR-TB) in adults and children (aged ≥5 years and weighing ≥15 kg). In the United States, Sirturo should only be used when other effective treatment regimens cannot be provided.

Based on the sputum culture conversion time, this indication has receivedFDAaccelerated approval. Continued approval for this indication will be contingent upon confirmatoryClinical TrialValidation and description of clinical benefit. Sirturo should not be used for the treatment of latent tuberculosis infection, extrapulmonary tuberculosis, drug-susceptible tuberculosis, or infections caused by non-tuberculous mycobacteria. The safety and efficacy of Sirturo in patients with multidrug-resistant tuberculosis (MDR-TB) co-infected with HIV have not been established due to limited clinical data.

This timeFDAApproval marks the first regulatory approval of the pediatric formulation of Sirturo, a key component of Johnson & Johnson’s global pediatric research and development (R&D) program. The new 20 mg tablets can be administered with water to patients who are able to swallow whole tablets, and should be taken with food. For patients who have difficulty swallowing whole tablets, the tablets can be dispersed in water prior to administration. To facilitate administration, the resulting dispersion can be further mixed with beverages or soft foods. Alternatively, the tablets may be crushed immediately before use and mixed with soft foods.

This approval is based on data from a single-arm, open-label Phase II study. The study enrolled pediatric patients aged 5 to under 12 years who had confirmed or suspected multidrug-resistant tuberculosis (MDR-TB) and were treated with half the adult dose of Sirturo® 20 mg tablets over 24 weeks, in addition to receiving a background regimen for MDR-TB. The application for the pediatric formulation was grantedFDAPriority Review.

Dr. Martin Fitchet, Global Head of Public Health at Johnson & Johnson, stated: “The first approval of the pediatric formulation of bedaquiline represents a significant advancement for children with multidrug-resistant tuberculosis. Tuberculosis is already a frequently neglected area in global health, and children with the disease are particularly vulnerable to infection. Modernized pediatric treatment is a critical step toward alleviating the suffering of these young patients and ending tuberculosis once and for all.”

Dr. Ruxandra Draghia-Akli, Global Head of Global Public Health R&D at Janssen Research & Development, stated, “Over the past decade, we have witnessed significant advances in tuberculosis innovation, particularly for the most difficult-to-treat forms. Johnson & Johnson is proud to drive this R&D effort for patients of all ages. This latest achievement from our pediatric bedaquiline program will provide a new tool to address multidrug-resistant tuberculosis in vulnerable populations.”

Tuberculosis is the world’s deadliest infectious disease, claiming approximately 1.5 million lives in 2018 alone—more than HIV and malaria combined. Although tuberculosis most commonly affects adults during their most productive years, an estimated 1.1 million children developed tuberculosis worldwide in 2018, with more than 200,000 deaths. However, according to the World Health Organization (WHO), these figures may underestimate the true burden of childhood tuberculosis.

In 2012, Sirturo was first approved in the United StatesFDAAccelerated approval for eligible adult patients, thisThe first new tuberculosis drug in over 40 years. In 2019,FDASirturo® 100 mg tablets have been approved as part of combination therapy for the treatment of multidrug-resistant tuberculosis (MDR-TB) in adolescent patients aged 12 to 18 years who weigh at least 30 kg (66 lbs). The drug is reserved for use only when an effective treatment regimen cannot be provided. Currently, Johnson & Johnson is conducting further studies in children aged 2 to 4 years and infants under 2 years of age.

Sirturo is a diarylquinoline antimicrobial indicated as part of combination therapy for the treatment of multidrug-resistant tuberculosis (MDR-TB) in adults and children (aged ≥5 years and weighing ≥15 kg).

In China, Sirturo® (bedaquiline fumarate tablets) was approved in December 2016 as part of combination therapy for the treatment of multidrug-resistant tuberculosis (MDR-TB) in adults aged 18 years and older. This product should only be used when other effective treatment regimens cannot be provided. Treatment with this product should be administered under direct observed therapy (DOT). (Bioon.com)

Original Source: U.S.FDA approves New Pediatric Formulation of SIRTURO (bedaquiline) as Part of Combination Therapy to Treat Children with Pulmonary Multidrug-Resistant Tuberculosis