dm+d

27777011000001109

New Medicines

Deltyba Pulmonary multi-drug resistant tuberculosis (MDR-TB) in adolescents and children

Information

Deltyba
Licence extension / variation
Otsuka
Otsuka

Development and Regulatory status

Licence withdrawn
Launched
None
November 2020 (but no longer licensed in UK after Brexit)
Jul 21EU CHMP adopted a positive opinion recommending an extension to the indication for Deltyba to allow use in infants. The proposed new indication is use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents, and children and infants with a body weight of at least 10kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. The CHMP also recommended the addition of a new 25 mg dispersible tablet [6].
Jun 21Otsuka decided to opt out of the conversion process for centrally authorised products (in the EU) to a GB MA. Therefore Deltyba is no longer licensed for use in the UK [5].
Nov 20Approved in EU [3].
Sep 20EU positive opinion for a change to the licence to extend use from only adults to adolescents and children. The proposed new indication is use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents and children with a body weight of at least 30 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability [2].

Category

A nitro-dihyroimidaz-oxazole derivative that inhibits mycolic acid synthesis, inhibiting formation of the mycobacterial cell envelope
In 2017, incidence of case notifications in the UK was 8.4 per 100,000 people, the lowest number and rate recorded since surveillance data were first available in 2000. Rate in the non UK-born population is 13 times higher than in the UK-born population, and 71% of all cases notified in 2017 were born outside the UK. Prevalence in England is much higher in large urban areas (40% of cases in London). TB in children accounts for >20% of all TB cases in many countries with high TB incidence [1].
Pulmonary multi-drug resistant tuberculosis (MDR-TB) in adolescents and children
Bladder instillation

Trial or other data

Mar 19In a PIII RCT of 511 pts, reduction in median time to sputum culture conversion over 6 months was not significantly different for delamanid + optimised background therapy vs. placebo. The hazard ratio was 1·17 (95% CI 0·91-1·51, p=0·2157). [4]