Eisai Receives Positive Alzheimer Study Results, While FDA Rejects Dacogen

Eisai has received mixed news this week, after news that Dacogen, Eisai and Astex Pharmaceuticals’ drug to treat a type of leukaemia, has been rejected by an independent advisory panel to the regulator in the USA.

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee voted 10 to 3 that statistics 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 pursued for the medication to be used as a treatment in adults aged 65 or older who are not considered candidates for induction therapy.

The supplemental New Drug Application is centred 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 those not on Dacogen.  In documents released prior to the ODAC meeting, the FDA staff commented that “the study failed to demonstrate benefit on statistical interpretation.”

Dacogen did reach a secondary endpoint for progression-free survival, but the FDA commented that, because the primary goal was not reached, the former should not be considered as a measure of Dacogen’s effectiveness.  The agency is expected to make their final decision by March 6.

Dacogen is already approved in the USA for the treatment of patients with myelodysplastic syndromes, a group of diseases in which the production of blood cells by the bone marrow is disrupted.  Astex licensed the treatment to Eisai which in turn sold rights outside of North America to Johnson and Johnson.

Targretin Reverses Alzheimer’s In Mice

Meanwhile; Eisai has received positive news after the publication of a study published in the journal Science showed that the Japanese drugmaker’s Targretin (bexarotene) reversed the signs and symptoms of Alzheimer’s disease in mice.

Research carried out by neuroscientists at Case Western Reserve University School of Medicine, found that using the drug in mice appeared to quickly reverse the pathological, cognitive and memory deficits caused by small soluble forms of amyloid beta.  Within six hours of administering bexarotene, soluble amyloid levels fell by 25% and the effects lasted up to three days.

Case Western Reserve researcher Gary Landreth, professor of neurosciences and senior author of the trial, noted that “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, Landreth warns against talk of a cure for Alzheimer’s, which is becoming increasingly common as life expectancy rises.

But there are major questions over whether the approach will ever work in humans.  Retinoids, the class of drugs which includes bexarotene, can also cause harmful side-effects.

Landreth 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”.

Links:
www.eisai.com
www.fda.gov
www.pharmatimes.com

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