Eisai loses panel vote on new Dacogen use

Posted under Blog, Companies, Dacogen, Diagnostics, Eisai, FDA expert panels, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

A federal advisory panel voted down Eisai's attempt to gain an approval for Dacogen as a treatment for acute myeloid leukemia. The pharma company has been trying to gain an OK to use the drug for elderly patients for whom chemo has failed. The advisers voted 10 to 3 against, making any formal approval unlikely. Story

Astex hammered after regulators diss Dacogen application

Posted under acute lymphoblastic leukemia, Astex Therapeutics, Blog, Companies, Dacogen, Diagnostics, Eisai, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Shares of Astex Pharmaceuticals ($ASTX) got hammered yesterday after regulators turned a skeptical eye on Eisai's request for an expanded use of Dacogen, a leukemia-related drug the biotech licensed to Eisai.

Ahead of tomorrow's scheduled FDA panel review for the treatment, the agency released its comment that Dacogen "failed to demonstrate benefit based on statistical interpretation," according to Dow Jones. Once investors got wind of the news they drove down the value of Astex shares more than 20%.

Even so, at least one analyst says Eisai has a good response when it presents its case Thursday.

"The wording in the press release may telegraph to investors a more rigorous interpretation by the FDA," George Zavoico, an analyst with McNicoll Lewis & Vlak, tells Bloomberg. "Eisai needs to say, 'Look, the result is really significant if you give us a little bit of leeway. This will be the first drug available for an unmet clinical need.'"

Dacogen is approved to treat myelodysplastic syndromes, a blood disorder that leads to AML.

- get the Dow Jones story
- here's the report from Bloomberg