SILVER SPRING, USA (Reuters) – A Group of advisers said Thursday that should require cardiac studies for new drugs against obesity, possibly adding a new obstacle in the way of approval.
Advisory Panel of the food and United States drugs (FDA) Administration issued 17 votes in favour and 6 against that regulators should require companies to conduct studies of the heart impact to sell their drugs in United States, even if clinical trials do not initially show evidence of cardiac risk.
“drugs against obesity have a negative history of cardiovascular risk,” said Dr. Marvin Konstam, Professor at the Tufts University School of medicine and a member of the Advisory Group.
The FDA, which usually follows the recommendations of the group, will take a decision later.
The news could affect Vivus and Arena Pharmaceuticals and Orexigen Therapeutics, which are competing to bring the first drug against obesity to the market in more than one decade.
The FDA previously ordered Orexigen Therapeutics heart study before considering the adoption of its pill to lose weight, Contrave.
Advisers were divided on whether companies should do a meta-analysis of existing data prior to the adoption, or if they would have to carry out a clinical study focused on heart safety before that medicines reach the market.
A new study would be much more expensive and will take more time, and some advisers warned against impeding investment in pharmaceutical research on obesity.
Most of the advisers agreed that the need for a study prior to the approval would depend on how much weight can generate the medication and what other risks has shown.
Also advised include patients with an increased risk of heart disease in tests, such as the elderly.
Obesity has become an epidemic in United States and has caused a large increase in health problems such as heart disease and diabetes.
But many drugs against obesity have failed or were abandoned because of security issues.
