Otsuka's response to open letter regarding delamanid compassionate use program.
On December 4, 2013 the Global TB Community Advisory Board (TB CAB), the Community Research Advisors Group to the Tuberculosis Trials Consortium (CRAG) and the Treatment Action Group (TAG) sent an open letter to Otsuka asking that delamanid be made available immediately under compassionate use to patients in urgent need. The TB CAB has been pressing Otsuka to implement a pre-approval access program since November 2011.
In their response, Otsuka indicates that while the European regulatory process for delamanid continues, the company has established a framework for reviewing compassionate use requests. This framework includes, but is not limited to, Otsuka’s agreement with Médecins Sans Frontières to supply delamanid for compassionate use within their network of treatment sites. However, to date only one patient in Europe has gotten delamanid under compassionate use, and many more need access.
Doctors, whose patients need urgent access to delamanid, can send requests for compassionate use of the drug to the following email address: email@example.com.
The open letter from community had also urged Otsuka to price delamanid affordably once it receives approval, to rapidly register it in countries affected by TB, and to commit to further research to optimize the use of the drug.
The company responds to that by committing to performing all of the above:
“In the past we have also discussed a number of topics regarding Deltyba (delamanid), from the need for affordable pricing upon approval, to ongoing registration in high-burden countries, and further research to optimize its use. Let me assure you that Otsuka is committed to performing all of the above.”
You can download Otsuka's response to the open letter from here.