Clinigen teams up with Horizon on RAVICTI

Clinigen Group was celebrating on Wednesday, as its Idis Managed Access division and Nasdaq-traded Horizon Pharma initiated a Managed Access Programme in Europe for Horizon’s RAVICTI oral liquid.

The AIM-traded firm said RAVICTI received centralised marketing approval from the European Medicines Agency in September.

It is indicated for the treatment of Urea Cycle Disorders in adults and children from two months old and over, who cannot be managed by dietary protein restriction or amino acid supplementation alone.

The Managed Access Programme, operated by Idis, will make RAVICTI immediately available to eligible patients living with Urea Cycle Disorders in selected European countries prior to commercial launch.

“Urea cycle disorders can be serious and even life threatening so it is important that treatment options like RAVICTI can be accessed by those patients who need it,” said Clinigen Group managing director Steve Glass.

“As the global leader in Managed Access programs, this partnership with Horizon enables us to use our expertise to support both Horizon and the UCD community in Europe, providing access to RAVICTI to help eligible patients who have no alternative option, ahead of the medicine's approval and commercial launch.”

Jeffrey Sherman, chief medical officer at Horizon Pharma, said as part of its efforts to address the unmet needs of people living with rare and challenging disorders, including Urea Cycle Disorders, it was partnering with Idis to make the programme available.

“Where local health authorities permit, the Managed Access Programme will allow healthcare professionals to have access to RAVICTI while Horizon works through its country-by-country plan to make RAVICTI commercially available in Europe.”