News

EMA Reverses Opinion on Delamanid for MDR-TB

Source: European Medicines Agency http://www.ema.europa.eu

On 21 November 2013, the Committee for Medicinal Products for Human Use (CHMP) recommended the granting of a conditional marketing authorisation for the medicinal product Deltyba for the treatment of lung infections due to multidrug-resistant tuberculosis when alternative treatments cannot be used due to resistance or intolerance. The company that applied for authorisation is Otsuka Novel Products GmbH.

On 25 July 2013, the CHMP had originally adopted a negative opinion for Delamanid in multidrug-resistant tuberculosis. At the request of the applicant, the CHMP started a re-examination of its opinion. Following the re-examination, the CHMP adopted a final positive opinion on 21 November 2013 recommending the granting of a conditional marketing authorisation for Deltyba, but restricting its use to treatment of tuberculosis affecting the lungs and to situations where alternative treatments cannot be used due to resistance or intolerance. Click here to to download the news release from EMA.

Additional Coverage:

CHMP Recommends Otsuka’s Deltyba™ (delamanid) for EU Approval for Treatment of Multidrug-Resistant Tuberculosis (MDR-TB) in Combination with Optimized Background Regimen (OBR)

Tuberculosis Drug Wins Backing of European Panel (WSJ)

View Delamanid on Global Pipeline–http://www.newtbdrugs.org/project.php?id=136

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