Clinigen Group PLC (LON:CLIN) has been appointed by US-listed drug developer Jazz Pharmaceuticals (NASDAQ:JAZZ) to provide access to the latter’s leukaemia treatment.
Clinigen specialises in managed access programmes which provide medicines to people in need where the product does not have regulatory sign-off in the local jurisdiction.
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The company will be the distributor for Vyxeos in the UK, Ireland, Germany, Poland, Belgium, Switzerland, Portugal, Spain and Canada.
Acute myeloid leukaemia
It will be prescribed to patients aged 60-75 with newly-diagnosed therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes.
"There is a huge unmet need for adults with AML where treatment options to date have been very few,” said John Lagus, head of managed access at Clinigen.
“Vyxeos provides the first FDA approved chemotherapy treatment for patients with certain types of high-risk AML in more than 40 years."