NHS England has issued a new clinical commissioning policy, which approved Janssen’s Situro to treat pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients.
The drug is recommended as an option for use within NHS Wales as part of an appropriate combination regimen for pulmonary MDR-TB in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
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In Scotland, due to the rarity of MDR-TB, the drug will be available through the route of individual funding requests.
Janssen medical director Dr Rozlyn Bekker said: "This announcement for bedaquiline demonstrates our commitment to delivering transformational medicines to address unmet public health needs in the UK and worldwide.
Bedaquiline clinical development programme comprised of two phase two studies in patients with MDR-TB.
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TMC207-C208 has been carried out in two independent stages, including stage I controlled, randomised and exploratory trial and stage two controlled and randomised superiority trial in MDR-TB patients.
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By GlobalDataStage two compared time to culture conversion following the use of bedaquiline, including 400mg once daily for two weeks followed by 200mg three times a week for 22 weeks, versus placebo in combination with a standardised background regimen for MDR-TB.
The study enrolled 160 patients who received bedaquiline for 24 weeks followed by continuation of the background therapy for an additional 18 to 24 months.
TMC207-C209 is an ongoing phase two open-label trial in MDR-TB patients, in which bedaquiline was administered as 400mg once daily for two weeks followed by 200mg three times weekly for 22 weeks in combination with an individualised background regimen for MDR-TB, followed by continued administration of the background regimen for 12 to 18 months.
The trial, which includes 233 patients in 11 countries, is designed to assess the safety and efficacy of bedaquiline in treatment-experienced patients, including 25% with pre-extensively drug-resistant TB (pre-XDR) and 21% with XDR-TB.
Janssen is partnering with the International Union Against Tuberculosis and Lung Disease (The Union) to include bedaquiline in the standardised treatment regimen of anti-TB drugs for patients with MDR-TB.
Image: Chest X-ray of a person with advanced tuberculosis. Photo: courtesy of James.
