Letters

TAG and the TB CAB send open letter to Otsuka to expedite plans to develop a pre-approval access program for delamanid for patients in urgent need, determine if delamanid is safe to use with bedaquiline, and develop the drug for pediatric use as rapidly and safely as possible.

TAG and TB CAB issue an open letter to Janssen, bedaquiline’s sponsor, about the need to accelerate pediatric research, to determine the safety of using bedaquiline and delamanid together, and to support Janssen’s compassionate use program to provide access to bedaquiline for people in urgent need in places where the drug has not yet been approved.

TAG and TB CAB send letter to FDA and to the EMA to encourage crucial regulatory harmonization on endpoints for tuberculosis drug development, and to encourage Otsuka and Janssen to conduct necessary drug-drug interaction studies on bedaquiline and delamanid.