There have been some important changes to the delamanid compassionate use protocol. Delamanid is available for compassionate use and can be obtained from the company at no charge on a patient-by-patient basis.
The company has made some changes to their access and eligibility criteria and these are summarized below. Perhaps most exciting is that the pediatric formulation of delamanid (a 25mg dispersible tablet) will also be available via compassionate use. This formulation is not yet on the market but is an important tool for younger children with RR-TB. We are thrilled the company has now made this formulation available for the children who need it.
Please find additional information below.
Updates to Delamanid Compassionate Use Protocol
- Male and female patients ≥ 3 years of age are eligible for CU DLM enrolment
- Prior delamanid use is no longer an exclusion criterion
DLM treatment duration
- The current protocol 242-302-00014 allows treatment extension of CU DLM on a case by case basis. Re-application for a treatment extension with delamanid can be made in exceptional cases, in order to minimize the probability of a resistance development to anti-TB treatment and/or enhance the likelihood of a favourable treatment outcome in difficult to treat cases.
- IMP of the pediatric formulation (dispersible tablets of 25 mg) is undergoing final packaging and testing and shall become available for patients enrolled in the updated CU protocol 242-302-00014 shortly.
PV reporting timelines
- The updated CU protocol 242-302-00014 requires reporting of all safety information within 24 hours (not just for SAE as in the previous CU protocol 242-12-401 but all AEs + safety information)