[Ip-health] Médecins Sans Frontières responds EMA approval of new tuberculosis drug delamanid

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Fri Nov 22 09:48:57 PST 2013

Médecins Sans Frontières responds EMA approval of new tuberculosis drug


Today it was announced that 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.

Médecins Sans Frontières responds with the below quote:

“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

Joanna Keenan
Press Officer
Médecins Sans Frontières - Access Campaign
P: +41 22 849 87 45
M: +41 79 203 13 02
E: joanna.keenan[at]geneva.msf.org
T: twitter.com/joanna_keenan


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