Belgian group UCB is being forced to recall its Parkinson’s disease patch Neupro in the US and certain batches in Europe, after uncovering a “deviation from the approved product specification”.
Although exact details of the problem have not been disclosed, Iris Loew-Friedrich, chief medical officer of the firm, stressed the issue is “not one of product contamination or toxicity but rather one of possibly reduced clinical performance of some patches”.
Whatever the problem, the finding means that supplies of Neupro (rotigotine) across the Atlantic will run dry at the end of next month, although stock is sufficient to weather the shortfall in Europe and other regions, the group said.
Down-titration strongly advised
However, as supplies will soon run out in the US, the firm is strongly advising healthcare professionals and patients not to abruptly stop their therapy, and that dosing should be gradually reduced instead under medical supervision to avoid certain complications.
Neupro was approved in the USA for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease in May last year, becoming the first patch to be approved for the condition, and generated global turnover of 52 million euros in 2007.
The full effect of the absence of its sales on UCB’s business is not yet known, as the timeframe for the resolution of the problem has not yet been determined. But according to the group, its 2008 financial outlook is under review and will be updated as soon as possible.
