FDA turns down Eisai drug application
WOODCLIFF LAKE, N.J. — The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said.
Eisai said the FDA delivered it a complete response letter for the chemotherapy drug Dacogen (decitabine) in patients ages 65 years and older with acute myeloid leukemia who are not candidates for induction therapy. The FDA delivers a complete response letter when questions remain about an regulatory application that preclude approval, usually due to insufficient clinical trial data.
The drug maker said the FDA’s decision was due to the primary study not providing convincing evidence of safety and effectiveness for AML. The drug already is approved for treating myelodysplastic syndromes, a group of cancers that result from damage to the cells in the bone marrow that form blood cells.
Shire to compare Vyvanse with competing drug in phase-4 trial program
PHILADELPHIA — Drug maker Shire will conduct two post-marketing trials to compare its treatment for attention deficit hyperactivity disorder with a competing drug, the company said Tuesday.
Shire announced that it would start two phase-4 trials comparing its drug, Vyvanse (lisdexamfetamine dimesylate), with Alza’s Concerta (methylphenidate hydrochloride).
Shire said the purpose of the trials was to find out possible differences in efficacy between the drugs and said such trials would provide important information to physicians, patients, caregivers and payers.
FDA declines to approve Merck cholesterol drug
WHITEHOUSE STATION, N.J. — The Food and Drug Administration is asking for additional data before it approves a new cholesterol drug made by Merck, the drug maker said.
Merck said the agency issued a complete response letter for its regulatory approval application for a drug that would combine the cholesterol drug Zetia (ezetimibe) with atorvastatin, the active ingredient in Pfizer’s Lipitor. A complete response letter means that the FDA cannot approve a drug application in its current form.
The proposed drug is similar to the drug Vytorin, which combines ezetimibe with simvastatin. Lipitor lost patent protection at the end of November, and Ranbaxy Labs markets a generic version.