On November 22, 2013, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting a conditional marketing authorisation for delamanid, only the second new TB drug to be developed in 50 years. It is hoped that the new drug, marketed by the Japanese company Otsuka, will be pivotal in improving treatment for drug-resistant forms of tuberculosis, including multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB). Current treatment regimens for drug-resistant forms of the disease–which are highly toxic, lengthy, expensive and effective only half the time–are entirely insufficient to mount an effective response to the disease.
Otsuka’s Phase III clinical trials for delamanid are now underway. The CHMP decision means that the drug can be marketed in European Union Member States for the treatment of adult patients with pulmonary infections due to multidrug-resistant tuberculosis when an effective treatment regimen cannot otherwise be devised for reasons of resistance or tolerability. Some EU countries, including Bulgaria, Estonia, Latvia, Lithuania and Romania, have very high rates of MDR-TB.
“EMA’s approval is a landmark decision and a critical step towards better options for people in desperate need of more effective and safer treatments for drug-resistant tuberculosis, but this is only one piece of the solution. What patients really need are all-new multidrug regimens, and clinical trials to test delamanid with other TB medicines are urgently needed if we are to radically improve treatment options.
To accelerate access and fully realise the potential of this new drug, we need open collaboration to test new multi-drug regimens, we need the drug to be registered widely especially in high-burden countries, and we need assurances that the drug won’t be priced out of reach of national TB programs.
In the meantime, seriously ill patients who have exhausted all other treatment options could be helped today if early access to the drug was made available through ‘compassionate use’ programs, and we hope Otsuka considers opening such a program.”
– Dr. Jennifer Cohn, Medical Coordinator, MSF Access Campaign