Bronchitol AdComm Shows Difficulty Of Following In Kalydeco’s Shadow

Comparisons between the robustness of the efficacy data for dry powder mannitol and Vertex’s ivacaftor were difficult for FDA to avoid during the Pulmonary-Allergy Drugs Advisory Committee’s Jan. 30 review of Pharmaxis’ cystic fibrosis drug.

The FDA advisory committee review of Pharmaxis Ltd.’s cystic fibrosis drug Bronchitol (mannitol inhalation powder) shows the difficulty faced by a new drug moving through the regulatory process shortly after a breakthrough treatment’s approval in the same disease.

The Pulmonary-Allergy Drugs Advisory Committee’s Jan. 30 review of dry powder mannitol (DPM) came almost one year to the day...

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