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."
FDA approves lower dose of Bayer’s Angeliq
WAYNE, N.J. — The Food and Drug Administration has approved a new formulation of a drug for postmenopausal women.
Bayer HealthCare Pharmaceuticals said the FDA approved a lower-dose formulation of Angeliq (drospirenone and estradiol) tablets, used to treat moderate to severe vasomotor symptoms due to menopause in women who have a uterus. The new formulation contains 0.25-mg drospirenone and 0.5-mg estradiol, while the previously approved formulation contained 0.5-mg drospirenone and 1-mg estradiol.
"We are pleased by the approval of this important new lower-dose option for menopausal women," Bayer HealthCare Pharmaceuticals VP and head of U.S. medical affairs Pamela Cyrus said. "The availability of the new lower dose of Angeliq supports current guidelines which recommend that treatment with hormone therapy should aim to use the lowest effective dose."