Posted by Michael Wonder on 22 Sep 2020
CHMP grants positive opinion for expanded use of Otsuka’s Deltyba (delamanid) in children and adolescents weighing at least 30 kg treated for pulmonary multi-drug resistant tuberculosis
21 September 2020 - This label extension of Deltyba (delamanid) represents a new treatment option for children and adolescents with pulmonary multi-drug resistant tuberculosis.
Otsuka Novel Products is pleased to announce that the CHMP of the EMA recommends approval of extension of the indication for Deltyba (delamanid) for children.
This means Deltyba (delamanid) is recommended by the CHMP for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis 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.
