ACADEMIC AND industry experts said yesterday they have convinced US regulators to ease safety restrictions imposed on clinical trials of Alzheimer’s drugs, a move that could improve the chances that a drug being developed jointly by Pfizer and Elan/Johnson Johnson might succeed.
A 2008 study of 240 patients testing that drug, known as bapineuzumab, found a dozen cases of a brain swelling condition called vasogenic oedema, shaking confidence in the safety of agents that reduce levels of a protein called beta amyloid that accumulates in the brains of Alzheimer’s patients.
That study prompted the US Food and Drug Administration (FDA) to issue stricter safety guidelines for clinical trials of drugs that alter amyloid in the brain, Maria Carrillo of the Alzheimer’s Association said in a telephone interview.
Under new guidelines ironed out through the Alzheimer’s Association’s Research Roundtable – which included both industry and academic researchers – the US drug administration has now eased those guidelines, said Ms Carrillo.“We don’t want to compromise safety but we also want to make sure as many people as possible can participate in Alzheimer’s clinical trials.”
Currently there are no drugs available that alter the course of Alzheimer’s, which affects some 26 million people globally and costs more than $600 billion a year to treat. – (Reuters)
