Positive Findings May Lift FDA Hold On Zafgen’s Obesity Drug Trials
Biotech giant Zafgen Inc. feels hopeful in the possible revival of FDA review process of its controversial obesity drug after the release of positive report on the company's experimental medication.
Following the deaths of two patients during its drug trials, the Food and Drug Administration (FDA) ordered a halt on experiments effectively leaving the regulatory approval process in limbo.
The findings on Phase III study regarding beloranib's (the lead drug) efficacy yielded unexpected positive comes. Results show that the drug can effectively reduce weight and curb excessive appetite in patients diagnosed with Prader-Willi Syndrome (PWS)- a genetically-influenced life-endangering obesity.
So far, no viable approved treatment exists for those who suffer from PWS which reportedly affects one in every 12, 000 to 15, 000 people.
"The fact that our drug is impacting both of the major issues that confront these patients is clearly a path forward," told Zafgen CEO Thomas Hughes as quoted by Reuters.
As the news went public, Zafgen's stocks soared high since shares plummeted in December. This indicated strong investor confidence in the pharma giant's ability to persuade FDA to reverse its earlier decision to stop the medication's clinical trials.
"This clear efficacy outcome is a crucial first step in moving discussions forward with the Food and Drug Administration regarding continued development of beloranib...we now have the robust data to provide greater perspective on the benefit/risk relationship of beloranib in this high-risk patient population," Zafgen's CEO further explained as mentioned by Wall Street Journal.
Zafgen managed to climb $11.88- the company's highest level since FDA's shutdown of its drug application in December last year according to a report by Bloomberg.