[Ip-health] MSF Responds to EMA approval of new tuberculosis drug delamanid

Michelle French Michelle.French at newyork.msf.org
Fri Nov 22 09:35:24 PST 2013

MSF Responds to EMA approval of new tuberculosis drug delamanid

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.

MSF response:

“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 

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

Michelle French
Communications Officer
Médecins Sans Frontières (MSF) - Access Campaign
Office: +1.212.763.5735 | Mobile: +1.646.552.4600
michelle.french at newyork.msf.org | Skype: michellejfrench
www.msfaccess.org | twitter.com/MSF_access | www.facebook.com/MSFaccess

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