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Delamanid

Delamanid (also known as OPC-67683) is in phase III trials for multidrug-resistant TB, and appears promising (read more about delamanid’s apparent safety and efficacy in TAG’s 2013 Pipeline Report). Delamanid recently received a recommendation from the Committee for Medicinal Products for Human Use (CHMP) to the European Medicines Agency (EMA) for marketing approval. However, delamanid is still not available to patients outside of clinical trials, as it has not yet been approved by any regulatory authorities, nor has delamanid’s sponsor, Otsuka, made it available for pre-approval access under a compassionate use or early access program. TAG and the Global TB Community Advisory Board (TB CAB) have requested that Otsuka 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 the TB CAB also followed up on delamanid and bedaquiline safety issues with letters to the FDA and the EMA. The U.S. National Institutes of Health is now coordinating efforts to determine what further research is necessary to evaluate whether bedaquiline and delamanid are safe to use together, and to conduct any requisite studies.

Since the TB CAB’s initial request to Otsuka for pre-approval access, Otsuka’s phase III trial has completed enrollment, their pediatric studies are well under way, and the drug is poised for EMA approval­—and yet, not a single patient has been able to get the drug outside of a safety or efficacy trial. The TB CAB has issued an urgent appeal for Otsuka to initiate its long overdue compassionate use program by the end of 2013. Patients with preextensively and extensively drug-resistant TB, and those who cannot tolerate existing second-line drugs for multidrug-resistant TB, cannot wait for delamanid’s registration and approval in their countries—they need access now, and it is unacceptable and irresponsible of Otsuka to delay initiation of their compassionate use program any longer.