Tuberculosis experts question evidence and safety data used to approve pretomanid in US -

Tuberculosis experts question evidence and safety data used to approve pretomanid in US
Information type: Media and commentaries
Source: British Medical Journal
Specialities: Infection and infectious diseases | Respiratory disorders
Summary
Two dozen leading TB clinicians and researchers have written to a leading TB charity to question FDA approval, which was hailed a “watershed” moment, due to concerns that sponsors may have hidden data on liver toxicity and approval based on inadequate evidence of efficacy/safety.
UKMi comment
In April 2019, a Marketing Authorisation Application for pretomanid was accepted by the European Medicines Agency for the treatment of drug-resistant or treatment-intolerant or non-responsive multi-drug-resistant TB in combination with bedaquiline and linezolid (BPaL regimen).
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