AUSTRALIAN biotechnology company Pharmaxis has confirmed the US Food and Drug Administration has rejected its bid to market the cystic fibrosis drug Bronchitol in the US.
The FDA recommended that Pharmaxis conduct an additional clinical trial to obtain approval for the drug.
"The submitted data do not provide a favourable benefit-risk balance to support the use of inhaled mannitol in patients with cystic fibrosis six years of age and older," the FDA said in a letter to Pharmaxis following its meeting on Monday.
"The determination of efficacy based on the two clinical trials are not adequate because of the treatment-related frequent early dropouts in trial 301 for which the primary statistical analyses did not account and the lack of statistical significance in trial 302 for the primary endpoint."
Shares in Pharmaxis, which were in a trading halt ahead of the announcement, rose by up to 6 per cent before falling following the lifting of the trading halt. It was trading 2 per cent lower at 49 cents about 1.20pm.
Read more at Brisbanetimes.com.au
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