Advisers to the FDA, the regulatory agency of the U.S. health care, recommended approval of which would be the first new drug for weight loss in over a decade, despite concerns about heart risks.
The stock prices of the drug’s maker, Arena Pharmaceuticals Inc., jumped from 3.66 to 7.15 dollars in transactions after the close of trading.
A panel of advisers to the Food and Drug Administration (FDA, for its acronym in English) voted 18 to 4 to recommend approval of lorcaserin medicine, because the benefits “outweigh the potential risks when used long term “people who are overweight or obese. One panel member abstained.
“We will continue working with the FDA as the agency completes its study,” said the president of Arena, Jack Lief said in a statement.
The company said the FDA set a deadline for decision on June 27. The medicine is aimed at people who are overweight or obese and at least one health problem related to weight, such as hypertension.
The FDA is not bound to accept the advice of advisory panels but usually does.
Lorcaserin is one of three experimental drugs whose creators try a second time to obtain approval from the FDA, which refused in 2010 or 2011 due to serious side effects.
Two days ago, federal regulators caused surprise with a favorable assessment of the medicine. When the agency rejected in 2010, its scientists expressed concern about tumors and other disorders caused in laboratory animals.
Subsequently, the pharmaceutical based in San Diego reiterated its request for approval accompanied by new data.
A research study by the FDA staff, published on the Internet, said the new analysis presented by Arena suggest that there is only a “negligible risk” of tumors in people taking the medicine.
However, questions remain about increasing the risk of hypertension in diabetics or heart valve damage, a serious side effect associated with other medications to lose weight.