A bid by Israel's Teva and Denmark's Lundbeck to get expanded use of Azilect has been boosted by late-stage data which shows that the drug may slow the progression of Parkinson’s disease.

The data, which was presented at the Congress of European Federation of Neurological Societies in Madrid, comes from the Phase III trial titled Adagio, the initial results from which were published in June. The study, which involved 1,176 patients, showed that those administered once-daily Azilect (rasagiline) for 72 weeks experienced significant improvements compared with those in the delayed-start treatment group, who received 36 weeks of placebo followed by 36 weeks of the Teva/Lundbeck drug.

Presenting the data, Olivier Rascol of University Hospital, Toulouse, one of two principal investigators of the trial, said that “the rigorous trial design and the fact that all three primary endpoints were met with statistical significance reinforce the quality of the data”. He added that they support the potential for Azilect to have an effect on disease progression".

This view was echoed by his co-principal investigator Warren Olanow of the Mount Sinai School of Medicine in New York. He said that “delaying disease progression is the most important unmet need in the management of Parkinson's disease," and the results show that early treatment with once-daily rasagiline 1mg “provided significant clinical benefits that were not obtained by those patients where initiation of Azilect therapy was delayed by nine months".

The drug is currently approved to treat the signs and symptoms of Parkinson's disease, but the companies are hoping to expand the drug's label to include disease modification. The data will be submitted to regulatory authorities in the USA (by Teva) and Europe (Teva and Lundbeck) so it can be incorporated on the therapy's label.

Second-quarter sales of Azilect reached $42 million, up 50%, but an expanded label could convert the drug into a blockbuster, analysts have predicted.