Boehringer Ingelheim gets EU approval for restless leg syndrome treatment

Boehringer Ingelheim has obtained a positive recommendation from the EMEA for the use of pramipexole in treating restless leg syndrome (RLS).

The drug, known by its brand names Sifrol and Mirapexin, is a dopamine agonist previously approved as a Parkinson’s treatment. Clinical tests conducted in Europe and the US found that it relieved RLS symptoms after a week of beginning treatment.

RLS is a neurological disorder which causes a patient to feel a painful need to move their legs. The condition affects ten per cent of adults aged between 30 and 79, and can cause individuals to become sleep deprived.

“The recommendation from the CHMP [Committee for Medicinal Products for Human Use]is a major step towards an approval for pramipexole in the European Union,” said Dr Andreas Barner of Boehringer Ingelheim.

He added: “Pramipexole is already well established in the treatment of Parkinson’s Disease – our hope is that soon RLS patients will be able to benefit from the efficacy of pramipexole in controlling not only the symptoms of RLS, but also in reducing the high impact of the disease on patients’ quality of life.”

The company is now awaiting marketing approval for the treatment, expected between April and June of this year.

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