WASHINGTON (Reuters) - U.S. freedom from disease regulators are asking for advice ~ward whether, and when, heart safety studies should be required for new obesity drugs, perchance adding a new hurdle on their avenue to approval.

An advisory panel to the U.S. Food and mix with ~s Administration will discuss this week whether regulators should edict such trials before the drugs can be marketed in the United States.

Ahead of the pair-day meeting that begins on Wednesday, FDA bat reviewers said the panel must bear the potential benefits to heart freedom from disease gained by helping people lose burden, versus a history of heart problems that be in actual possession of cropped up in longer-term clinical studies of slimming drugs.

"Obesity affects millions of race in the United States and increases the risk of premature death and cardiovascular ail," FDA staff said in documents released online up~ the body Monday.

"Thus, the cardiovascular charge of drugs developed for the handling of obesity is an important general health issue."

The discussion comes in the same manner with a new crop of obesity drugs abide a decision on marketing approval from the FDA. They are the before anything else such treatments that may reach the emporium in over a decade, and frequent expect their manufacturers will be required to bear up out follow-up studies on fortitude risks.

The agency is set to decide in middle-April on Vivus Inc's Qnexa. Outside advisers are fit to review Arena Pharmaceuticals Inc's lorcaserin in May, in which case Contrave by Orexigen Therapeutics Inc has different more years of trials ahead.

Obesity has be converted into an epidemic in the United States, ruling to a huge increase in diabetes and a throng of related health problems, including vital part disease. But many potential weight-detriment drugs have either failed or been unprincipled due to safety issues.

In persons health studies, weight loss has generally been tied to positive effects steady the heart, including lower blood compressing, FDA reviewers said.

But a hardly any trials of the long-term core safety of obesity drugs have shown they positively increase heart risks, or have none effect on heart health, the FDA rod said.

The infamous diet drug "morass-phen" was pulled from the emporium in 1997 after reports of at times fatal heart-valve problems.

And Abbott Laboratories pulled its ponderousness-loss drug Meridia from the U.S. place of traffic in 2010 after a study showed it increased the expose to danger of heart attacks and stroke in more patients.

The FDA already requires makers of pills in quest of Type 2 diabetes to prove their drugs complete not increase the risk of core attacks or other heart problems, and to standard patients who may be at higher peril for heart disease, such as the somewhat advanced in life.

The panel will vote on Thursday ~ward whether obesity pills that have not at all heart safety signals in clinical trials should motionless have to prove they do not become greater heart risks before they are approved, and for what cause to design the heart studies.

Cory Kasimov, analyst at JP Morgan, said it may take the FDA a different year or more to issue decisive guidance on heart trials for obesity drugs.

"With this timeline in judgment, and the pressure on the FDA to suit the obesity issue, we don't give attention to a significant delay for Qnexa during the time that likely," Kasimov said in a scrutiny note.

The panel's suffrage this week is also unlikely to have an impact on development of Orexigen's Contrave, at the same time that the company is already testing organ of circulation safety after an initial rejection from the FDA.

And by Arena Pharmaceuticals' lorcaserin, U.S. drugs regulators were added concerned about cancerous tumors found in rats.

Vivus shares were prostrate 0.3 percent at $21.25 forward Nasdaq on Monday afternoon and Orexigen shares were unchanged at $4.89.

Shares of Arena Pharmaceuticals climbed 20 percent in the pattern of the European Health Agency accepted the concourse's application for lorcaserin.

(Reporting by Anna Yukhananov; Editing by Michele Gershberg and Tim Dobbyn)

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