US drugmaker Onyx Pharmaceuticals (Nasdaq: ONXX) is partnering with UK-based Idis Limited to initiate a managed access program for carfilzomib in certain countries in Europe for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib (Johnson & Johnson’s Velcade) and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Managed access programs provide biopharmaceutical companies with a way to allow eligible patients ethical access to medicines for unmet medical needs. Access is provided in response to physician requests in a fully compliant manner, where no alternative treatment options are available. Carfilzomib has been approved in the USA under the brand name Kyprolis, and was granted orphan status in Europe in 2008, but has yet to be approved for marketing in the European Union.
“Patients with advanced cancer face unique challenges, among them, gaining timely access to innovative new therapies,” said Tony Dutta, managing director of Idis, adding: “Through our work with Onyx Pharmaceuticals, we will share our expertise in successfully addressing access challenges and help educate a broad range of stakeholders on navigating the options and obstacles that exist for these patients.”
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