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.
Takeda unit starts trial of lymphoma drug
CAMBRIDGE, Mass. — Takeda Pharmaceutical’s cancer drug unit has started a late-stage clinical trial of a drug for treating a rare form of lymphoma, the company said.
The unit, Millennium, announced the start of a phase-3 trial to evaluate MLN8237 in patients with relapsed or refractory peripheral T-cell lymphoma, an aggressive non-Hodgkin’s lymphoma.
"There is a significant unmet need for patients suffering from PTCL," Millennium chief medical officer Karen Ferrante said. "MLN8237 is being explored across a broad range of hematological malignancies and solid tumors. The initiation of this trial represents another major achievement in advancing the Millennium pipeline."