EU Marketing Authorisation Application Review of Bronchitol

27th Jun 11

Release Date: 27/06/2011 12:00am

Pharmaxis announced today that the Committee for Medicinal Products for Human Use (CHMP) have, at this point, refused the marketing authorisation for Bronchitol® for the treatment of cystic fibrosis and have now provided the reasoning behind reaching this opinion.This opinion is consistent with the trend vote taken by the CHMP at its May meeting, and advised publically by Pharmaxis on 25 May 2011.

The major concern of the CHMP that lead to the refusal was their view that the effectiveness and benefit of Bronchitol had not been established. In particular, that it was not clear to the CHMP that the improvement in lung function would be sufficient to improve the patient's condition and that the extent of the improvement was difficult for them to ascertain since the results of the studies were, in their view, inconsistent across the different age groups.


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