Jazz to put Clinigen on the 'MAP' for its AML drug
The US Food and Drug Administration (FDA) approved Vyxeos (daunorubicin and cytarabine) liposome for injection in August last year, and in November Jazz submitted the product for European approval to treat adults with high-risk acute myeloid leukemia (AML).
But as it awaits approval, the firm has contracted services firm Clinigen to distribute the drug via a Managed Access Program (MAP) for the treatment of adults aged 60-75 in the United Kingdom, Ireland, Germany, Poland, Belgium, Switzerland, Portugal, Spain and Canada.
“A Managed Access Program, or MAP, is a mechanism by which a pharmaceutical or biotech company can provide early access to their product on an unlicensed basis whilst the product is going through the regulatory approval process i.e. still in the clinic,” a Clinigen spokesperson told this publication.
In Europe, it is called ‘compassionate use’ and companies often outsource this pre-approval process to a third-party partner.
“This product is approved by the FDA in the US, it’s not approved outside the US. Therefore a MAP has been set up to allow physicians to request access for their patients on an unlicensed based outside the US and in certain territories,” the firm continued.
“Once the product is approved in those territories, the MAP ceases as the product would be licensed.”
While no financial details were revealed, Clinigen told us it has managed over 220 MAP and worked with Jazz before.
