Boehringer Ingelheim announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending the approval of a once daily formulation for Mirapexin/Sifrol (pramipexole), in all countries of the European Union, Norway, Iceland and Liechtenstein.
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 (without levodopa) or in combination with levodopa, ie, over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations).
The CHMP recommendation follows clinical trial results confirming the high therapeutic benefits of Mirapexin/Sifrol also when administered in a convenient once-a-day formulation.
“We are very pleased about the positive recommendation. This effective new treatment option combines the trusted clinical benefits of Mirapexin with the convenience of a single daily dose. The once daily administration of the new Mirapexin prolonged-release formulation has been shown to cause less frequent fluctuations in the pramipexole plasma concentration over 24 hours compared to the three times daily administration of pramipexole immediate release tablets. Once approved, PD patients already taking Mirapexin may be switched overnight from the immediate release tablets to the Mirapexin prolonged-release tablets, at the same daily dose. 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,” commented Dr Manfred Haehl, MD, Senior Vice-President Medicine at Boehringer Ingelheim Corporate Headquarters.
A new drug application (NDA) for a once daily, extended release formulation of Mirapex is in review with the US Food and Drug Administration (FDA) for the treatment of Parkinson’s disease (currently available in the USA as immediate release formulation).
Boehringer Ingelheim is looking forward to making the new formulation available to patients with Parkinson’s disease in the USA should the FDA approve the filed submission.