EU approval for Janssen-Cilag's Dacogen and Novartis/Vectura's Seebri Breezhealer

The European Commission on Friday approved the marketing authorization for Janssen-Cilag’s (a unit of US health care giant Johnson & Johnson [NYSE: JNJ]) Dacogen (decitabine) for the treatment of adult patients (age 65 years and above) with newly diagnosed de novo or secondary acute myeloid leukemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy. Dacogen also has been granted Orphan Drug designation for the treatment of AML.

The news is also an important milestone for the USA’s Astex Pharmaceuticals (Nasdaq: ASTX), which co-developed the drug and receives royalties (starting at 20% and escalating to a maximum of 30%) from Japanese drug major Eisai (TYO: 4523) on global sales. Dacogen, which is already approved in more than 30 countries for the treatment of myelodysplastic syndromes (MDS) was licensed by Astex to Eisai who in turn licensed marketing rights to Janssen-Cilag for Europe and all other markets outside the USA, Canada and Mexico.

The news represents a number of notable firsts: Dacogen becomes the world’s first drug to be approved for elderly AML. Median survival for this AML averages a mere 2.4 months and older sufferers have limited options for therapy; the approval is the drug’s first for the treatment of AML. Until now, the product had only been approved in 30 countries to treat MDS; and the approval is Dacogen’s first regulatory clearance in Europe.