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EU approves once daily Parkinson's therapy

The EU has approved Boehringer Ingelheim's once daily Parkinson's treatment, Mirapex/ Sifrol in all EU/ EEA countries

The European Commission (EU) has granted marketing authorisation to Boehringer Ingelheim for Mirapex/ Sifrol (pramipexole); a once daily, prolonged release treatment for early and advanced idiopathic Parkinson's disease in all EU/ EEA countries.

Results from clinical trials showed the new once daily prolonged release tablet had a comparable efficacy and safety profile to that of the immediate release tablet taken three times a day. Additional data showed that patients can switch from the three-times-a-day regimen to once-a-day easily and at the same dose.

"The European approval of the new formulation marks another big step in meeting patients' needs and represents a milestone for this worldwide highly successful treatment for Parkinson's disease. We are very pleased that due to the robust evidence base, the regulatory review experienced no delay, which will allow the first European countries to make the once daily tablet available to patients," said Dr Manfred Haehl, senior vice-president medicine at Boehringer Ingelheim.

Boehringer Ingelheim's pramipexole compound was first approved in 1997. It is currently apporved, either in combination with levodopa or as a monotherapy, in over 70 countries worldwide, for the treatment of the signs and symptoms of early and advanced idiopathic Parkinson's disease. In 2006, the therapy was also indicated as a treatment for the symptoms of moderate to severe idiopathic Restless Legs Syndrome (RLS).

Mary Baker, MBE, president of the European Federation of Neurological Associations (EFNA), commented on the European approval of the new formulation: "Most people with Parkinson's disease take many different pills on a daily basis, to manage their [Parkinson's disease] symptoms and other concomitant conditions. Being able to reduce their pill burden without foregoing the effectiveness will be welcomed by patients as well as by their care givers as it is expected that a once-daily administration can improve patient adherence to their treatment regimen."

14th October 2009

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