German pharmaceutical and chemical company Altana has withdrawn its marketing application for respiratory drug Daxas (roflumilast) in Europe after consultation with the European Medicines Agency.
The company said it will still pursue a European filing for Daxas, a phosphodiesterase-4 inhibitor for chronic obstructive pulmonary disease and asthma, but will have to bolster the dossier with additional clinical data.
In a statement, Altana said it is ‘committed to continue the development of Daxas and will pursue further clinical studies to strengthen the anti-inflammatory product profile and possible market potential of Daxas’.
The development of Daxas – which along with corticosteroid drug Alvesco (ciclesonide) are the two main products in Altana’s near-term pipeline – has been under something of a cloud since Pfizer pulled out of a licensing agreement for the drug earlier this year.
At the time, there was speculation that Altana would be facing a three-year delay for the Daxas programme, while in the USA development had also been held up by difficulties in recruiting patients into trials.
Meanwhile, Alvesco has had its problems as well. Despite being approved in more than 30 countries around the world, it has thus far failed to crack the USA, having received an approvable letter towards the end of last year after a study threw up a small number of patients who developed lens opacity.
Problems with the two lead compounds have led to persistent rumours – strongly denied by the company – that Altana may divest its drug unit.
