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Insmed Incorporated Message Board

  • califflaa califflaa Apr 7, 2014 3:11 AM Flag

    Some colour on the EMA timeline

    [ Beerse, Belgium, (March 06, 2014) - Janssen-Cilag International NV (Janssen) announced today that the European Commission (EC) has granted conditional approval to SIRTURO® (bedaquiline) in the European Union, for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients, when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

    The decision from the EC follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the approval of bedaquiline on December 20, 2013. ]

    [ In Phase 2 studies, the SIRTURO® treatment group had a decreased time to culture conversion and improved culture conversion rates compared to the placebo treatment group. The median time to culture conversion was 83 days for the SIRTURO® treatment group, compared to 125 days for the placebo treatment group at week 24 ]

    Hmm ... culture conversion in the placebo group? Perhaps they were snorting lines of lip when nobody was watching. Rumour has it that empty liposomes are deadly against the TB cell wall

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