Bedaquiline fumarate is under clinical development by Johnson & Johnson and currently in Phase II for Leprosy. According to GlobalData, Phase II drugs for Leprosy does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Bedaquiline fumarate LoA Report. Buy the report here.
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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Bedaquiline fumarate overview
Bedaquiline Fumarate (Sirturo) is a diarylquinoline antimycobacterial drug. It is formulated as tablets for oral route of administration. Sirturo is indicated as part of combination therapy in the treatment of adult and pediatric patients 5 years and over with pulmonary multi-drug resistant tuberculosis (MDR-TB), also indicated for use as part of an appropriate combination regimen in adult and paediatric patients (5 years to less than 18 years of age and weighing at least 15 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid.
It is under development for the treatment of treatment-refractory mycobacterium avium complex-lung disease, pumonary tuberculosis in adults and pediatric patients (5 years to less than 18 years of age and weighing at least 15 kg).
Bedaquiline was also under development for the treatment of multibacillary leprosy. It was under development for pulmonary multi-drug resistant tuberculosis (MDR-TB).
Johnson & Johnson overview
Johnson & Johnson (J&J) researches, develops, manufactures, and sells pharmaceutical products and medical devices. The company conducts business through its operating companies. It provides pharmaceuticals for immune disorders, cancer, neurological disorders, infectious, cardiovascular, and metabolic diseases; and medical devices for use in cardiovascular, orthopaedic, neurovascular care, general surgery and vision care fields. J&J distributes pharmaceutical and medical products to retailers, wholesalers, healthcare professionals and hospitals. The company offers its products in the US; Europe; Asia-Pacific and Africa; and Western Hemisphere (excluding the US) and Latin America. J&J is headquartered in New Brunswick, New Jersey, the US.
For a complete picture of Bedaquiline fumarate’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
