Eisai and Astex Pharmaceuticals have suffered a setback with the news that advisors to the regulator in the USA have not recommended approval of Dacogen for a type of leukaemia.
Specifically, the US Food and Drug Administration’s Oncologic Drugs Advisory Committee voted 10 to 3 with one person abstaining that data in Eisai’s supplemental New Drug Application for Dacogen (decitabine) for injection did not support a favourable benefit-risk profile for the treatment of acute myeloid leukaemia. The approval is being sought for the drug to be used as a treatment in adults aged 65 or older who are not considered candidates for induction therapy.
The sNDA is based on Phase III data in 500 patients who received Dacogen or best supportive care which showed that patients on the drug lived for an average of 7.7 months, compared with five months for the other arm. In documents released ahead of the ODAC meeting, FDA staffers said "the study failed to demonstrate benefit on statistical interpretation."
The drug did reach a secondary endpoint for progression-free survival, but the FDA said that, because the primary goal was not reached, the former should not be considered as a measure of Dacogen's effectiveness. The agency is due to make its final decision by March 6.
Dacogen is already approved in the USA for the treatment of patients with myelodysplastic syndromes. Astex licensed the treatment to Eisai which in turn sold rights outside of North America to Johnson and Johnson.
Targretin reverses Alzheimer's signs in mice
Much better news for Eisai came on the publication of a study published in the journal Science which shows that the Japanese drugmaker's Targretin (bexarotene) reversed the signs and symptoms of Alzheimer’s disease in mice.
Research by neuroscientists at Case Western Reserve University School of Medicine showed that use of the drug in mice appears to quickly reverse the pathological, cognitive and memory deficits caused by small soluble forms of amyloid beta. Within six hours of administering bexarotene, however, soluble amyloid levels fell by 25% and the effect lasted as long as three days.
Case Western Reserve researcher Gary Landreth, professor of neurosciences and senior author of the trial, said "this is a particularly exciting and rewarding study because of the new science we have discovered and the potential promise of a therapy for Alzheimer's". However, he insisted that "we need to be clear; the drug works quite well in mouse models of the disease. Our next objective is to ascertain if it acts similarly in humans. We are at an early stage in translating this basic science discovery into a treatment".