FDA approves Takeda’s Edarbyclor
DEERFIELD, Ill. — The Food and Drug Administration has approved a new drug for high blood pressure made by Takeda, the drug maker said.
The Japanese drug maker received approval for Edarbyclor (azilsartan medoxomil and chlorthalidone) for the treatment of high blood pressure, also known as hypertension. The company called it the only fixed-dose therapy that combines an angiotensin II receptor blocker with chlorthalidone, a diuretic, in a once-daily, single tablet. The company also markets Edarbi, which only contains azilsartan medoxomil.
"Hypertension is a complex disease that affects one-in-three Americans," Virginia Commonwealth University Medical Center professor Domenic Sica said in a statement on behalf of Takeda. "It is critical to control hypertension because lowering blood pressure has been shown to reduce the risk of serious health consequences, including stroke and heart attack."
Impax seeks approval for Parkinson’s disease treatment
HAYWARD, Calif. — The branded subsidiary of Impax Labs has submitted a new drug application for its investigational idiopathic Parkinson’s disease treatment to the Food and Drug Administration.
Impax Pharmaceuticals said Wednesday that IPX066 — an extended-release capsule formulation of carbidopa-levodopa — has undergone several studies in patients that have early and advanced stages of the disease. IPX066 is not approved or licensed anywhere in the world, the drug maker said, but the company did note that the drug is being developed in collaboration with GlaxoSmithKline for territories outside the United States and Taiwan.
“In just three-and-a-half years, Impax’s brand research and development team has successfully advanced IPX066 from an investigational new drug through multiple clinical studies of efficacy and safety, culminating in our NDA submission,” Impax Pharmaceuticals president Michael Nestor said. “This event demonstrates our strong internal capability to develop neurology products to fulfill unmet clinical needs of the PD community. IPX066 represents a significant commercial opportunity for Impax in the U.S., which if approved we plan to commercialize with our specialty neurology sales team.”
Second phase-3 study of TC-5214 did not meet primary endpoint
WINSTON-SALEM, N.C. — AstraZeneca and Targacept released results of the second of four phase-3 clinical trials that investigated the efficacy and tolerability of a drug that could serve as an adjunct therapy to major depressive disorder patients that had an inadequate response to initial antidepressant therapies.
The drug makers noted that the study did not meet its primary endpoint of change after eight weeks of treatment with TC-5214, compared with placebo. In this study, TC-5214 overall was well tolerated in the second study of the Renaissance program and showed an adverse event profile "generally consistent" with prior clinical trials of TC-5214.
The study results were in line with the first Renaissance study conducted by AstraZeneca and Targacept.
The two remaining efficacy studies in the program for TC-5214 are fixed dose trials, the companies noted.