Savient Pharmaceuticals, Inc. has announced that KRYSTEXXA(R)(pegloticase) is now available in the European Union to healthcare professionals and their patients suffering from refractory chronic gout (RCG) through a Named Patient Programme, which is sponsored by its wholly-owned subsidiary, Savient Pharma Ireland Limited, and managed by Idis Limited (Idis).
RCG is a difficult-to-treat form of gout and currently there are no other available therapies approved in the European Union for the treatment of RCG. KRYSTEXXA is currently available in the U.S. and is the only U.S. Food and Drug Administration approved treatment for RCG.
“In responding to prescriber and patient requests for access to KRYSTEXXA in the European Union, we are pleased to have established this Named Patient Programme in collaboration with Idis as we continue to advance our efforts to ensure that patients suffering from RCG have access to KRYSTEXXA.
“We believe that KRYSTEXXA can address a significant unmet medical need globally and we remain committed to provide this therapy to those patients who suffer from this crippling, debilitating disease and have no other treatment options available to them,” said Kenneth Bahrt, M.D., Senior Vice President and Chief Medical Officer of Savient Pharmaceuticals, Inc.
“We are pleased to be working with Savient to ensure that those patients with RCG have access to KRYSTEXXA through this Named Patient Programme,” said Natalie Douglas, Chief Executive Officer, Idis.
“We remain deeply committed to working in partnership with companies like Savient to give physicians and their patients access to new and innovative medicines through fully compliant channels.”
Idis develops and implements Managed Access Programmes that allow patients with unmet medical needs to access medicines that are not available through the traditional clinical trial or commercial framework.
For this programme, Idis will facilitate access to KRYSTEXXA on a named patient basis to European hospitals, pharmacies and physicians on behalf of their patients.
Under a Named Patient Programme, treatments that are pending approval by the European Medicines Agency (EMA) can be legally administered to patients who are suffering from serious diseases until they are commercially available in each market.
Savient is seeking approval for KRYSTEXXA in Europe and filed its regulatory application with the EMA in May 2011.