Sunday, 10 February 2013

Bronchitol™: Future Prospects in the US

This is a follow-up to the detailed commentary on the decision - Bronchitol: Power to the Patient

Several of the FDA committee members seemed to want to recommend Bronchitol™ because they could see it would be a valuable treatment option for some patients. However, they felt the Company had not provided them with sufficient evidence to safely predict which patients would benefit from the drug in a way that justified the risks. Some of the committee members said they might be more comfortable if it was restricted to CF adults with FEV1 of 40-70% rather than anyone aged 6 or over.

As for the drug's future prospects in the US, Pharmaxis announced the FDA decision a couple of hours after it was made on 30 January 2013 and then immediately followed by announcing a $40m capital raise to support the continued development and commercialisation of Bronchitol™ for CF in the EU and US. Clearly this implies the Company intend to try again with the FDA and, perhaps, that they were expecting a negative initial decision. 

Given Bronchitol is approved and marketed in other jurisdictions, it looks like Pharmaxis have a revenue stream for the drug that will allow them to sit on it for a while and look for patterns in usage of the drug in the EU and Australia and perhaps set up another trial to give them a better idea of the type of patients that benefit. With or without another study, based on the existing body of data and clinical experience outside the US, it seems likely that Pharmaxis will re-approach the FDA in the future with a restricted indication (e.g. excluding patients under the age of 18 and perhaps with a 40% threshold FEV1) and an enhanced monitoring/risk minimisation plan in line with the EU approval. 

You can access the meeting materials and recorded webcast here: PADAC Materials and Webcast


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