dm+d

24564711000001103

New Medicines

SirturoMulti-drug resistant tuberculosis in children and adolescents - add-on therapy

Information

Sirturo
Licence extension / variation
Janssen-Cilag
Johnson & Johnson

Development and Regulatory status

Launched
Launched
Launched
January 2020
Jan 21Use from age 5 recommended for EU approval by CHMP - the amended indication is "or use as part of an appropriate combination regimen for pulmonary multidrug‑resistant tuberculosis (MDR‑TB) in adults and paediatric patients (5 years to less than 18 years of age and weighing at least 15 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1)" [10].
Jan 20Approved in the EU [9].
Dec 19Recommended for EU approval by CHMP - the amended indication is ”for use as part of an appropriate combination regimen for pulmonary multidrug‑resistant tuberculosis (MDR‑TB) in adults and adolescent patients (12 years to less than 18 years of age and weighing at least 30 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents." [7]
Aug 19 U.S. FDA has granted approval for bedaquiline tablets as part of combination therapy in those over the age of 12 and younger than 18 and weighing at least 66 pounds (30 kilograms) – with pulmonary multidrug-resistant tuberculosis (MDR-TB), when an effective treatment regimen cannot otherwise be provided [4].
Jun 19Currently pre-registration in EU [3].
Mar 17EU filing will be via the centralised procedure [2].

Category

Mycobacterial ATP synthase inhibitor
The number of people with TB in England has fallen to 4,655 in 2018.The incidence of TB in 2018 (8.3 per 100,000population) was the lowest TB rate ever recorded in England. The overall rate of TB in children (<15 years) born in the UK, in 2018 was 1.2 per 100,000 and <50 people had multi-drug resistant TB in 2018. [6]
Multi-drug resistant tuberculosis in children and adolescents - add-on therapy
Oral

Trial or other data

Dec 19PII (NCT02354014) study is still recruiting with an estimated primary completion date of March 2021.[5]
Mar 17PII (NCT02354014) study is still recruiting [3].
May 16PII (NCT02354014) study to evaluate the safety, tolerability, pharmacokinetics, and anti-mycobacterial activity of bedaquiline (TMC207) in children and adolescents (0 months to less than [<] 18 years of age) diagnosed with confirmed or probable pulmonary multidrug resistant tuberculosis (MDR-TB), in combination With a background regimen of MDR-TB medications starts. 60 children will be enrolled in India, the Phillipines, Russia and South Africa. Collection of primary outcome data is expected to complete Mar 21 [2].

Evidence based evaluations