FDA has denied approval to market the drug, Bronchitol, manufactured by the Australian biotechnology company, Pharmaxis, in US market.
The dry powder formulation of mannitol (Bronchitol) is designed to treat cystic fibrosis. It is approved in Australia for patients above six years of age and for adults above 18 years old in European Union.
AdvertisementThe review committee has rejected the approval stating that an additional trial is required to prove the efficacy of the drug. FDA has noted that the first two clinical trial data submitted by the company do not meet benefit- risk balance. The first trial had too many early dropouts while the second study failed to produce statistically significant results.
Gary Phillips, CEO of Pharmaxis has announced that the company is ready to work with FDA and take the required measured to gain approval.