The CHMP of the European Medicines Agency (EMEA) has recommended the approval of a once-daily formulation for Mirapexin/Sifrol (pramipexole) throughout the EU.
The CHMP recommendation states that the new prolonged-release formulation is indicated for treatment of the signs and symptoms of idiopathic Parkinson’s disease, alone or in combination with levodopa.
"This effective new treatment option combines the trusted clinical benefits of Mirapexin with the convenience of a single daily dose,” commented Dr. Manfred Haehl, Boehringer Ingelheim’s MD and Senior Vice-President, Medicine.
“In addition to benefiting from the high therapeutic value of Mirapexin, the reduced pill burden will mean added convenience for patients and their carers. It is important for physicians to have effective and flexible treatment regimens to choose from so that they can offer individualised treatments in line with the patient’s needs," Haehl added.
Pramipexole was first approved in 1997 for the treatment of the signs and symptoms of idiopathic Parkinson’s disease, as monotherapy or in combination with levodopa. It was also was approved in 2006 to treat the symptoms of moderate to severe idiopathic Restless Legs Syndrome (RLS).