|FDA To Take Another 3 Month Review and Requested an REMS for Vivus's Qnexa Diet Pill|
|By Staff and Wire Reports|
|Monday, 09 April 2012 19:34|
Drugmaker Vivus Inc. (NASDAQ: VVUS) said regulators will take a three month PDUFA extension to make a decision on its closely-watched obesity drug Qnexa, which could become the first new prescription weight loss pill to reach the market in more than a decade.
The FDA informed Vivus that it will decide whether to approve Qnexa by July 17 as it needs more time to review the company's risk evaluation plan for the drug. The previous FDA action date for Qnexa had been April 17.
Vivus's Qnexa is one of three experimental new weight loss drugs seeking FDA approval after initial rejections by the agency. Arena Pharmaceuticals Inc (NASDAQ:ARNA) and Orexigen Therapeutics (NASDAQ:OREX) are also hoping for better news from the FDA after rejections of their diet pills.
After an advisory panel to the FDA in February voted overwhelmingly to recommend approval of Qnexa, saying that its benefits outweighed the risks, hopes that the first new obesity treatment would be approved for sale in the United States in more than a decade soared -- along with Vivus's share price.
But the FDA requested a Risk Evaluation and Mitigation Strategy (REMS) plan from the company, which the agency considers a major amendment to the approval application requiring further review time.
"The Qnexa REMS submission is comprehensive, with materials based on ongoing feedback from the FDA since our advisory committee meeting in February," Vivus Chief Executive Leland Wilson said in a statement.
"We look forward to finalizing our REMS with the FDA while we move forward with our commercialization plans," Wilson added.
Qnexa, which combines the appetite suppressant phentermine and the anti-seizure drug topiramate, helped patients on average lose at least 10 percent of their weight after a year of treatment in pivotal clinical trials.
With about a third of Americans deemed obese and some two thirds classified as overweight, the FDA has been under mounting pressure to approve a new weight loss treatment. But high profile safety problems with past diet drugs and the knowledge that a huge portion of the population will be tempted to take any new diet pills has left the FDA reluctant to approve them.
The FDA could still require Vivus to conduct additional studies to rule out heart problems as it has done with Orexigen's Contrave, or could allow Vivus to conduct such studies after the drug is already on the market.
Vivus shares fell 6.4 percent after the delay was announced, slipping to $21.45 in extended trading from their Nasdaq close at $22.92.
The U.S. FDA approved Eli Lilly's (NYSE:LLY) radioactive dye, called Amyvid, to help doctors rule out whether patients have Alzheimer's, the most common form of dementia.
The dye binds to clumps of a toxic protein called beta amyloid that accumulates in the brains of patients with Alzheimer's. Doctors can then see the plaque light up on a positron emission tomography, or PET, scan.
Patients with Alzheimer's always have some brain plaque, so its absence in the test would tell doctors to look for other causes of mental decline, such as depression or medications, Lilly has said.
But Lilly, which plans to sell the drug through its unit Avid Radiopharmaceuticals Inc, said the test should not be used to diagnose Alzheimer's, since brain plaque can also be tied to other neurologic conditions and may occur naturally in older people with normal mental states.
An FDA advisory panel recommended against approving the dye last year, saying doctors might have trouble interpreting scans of the plaque, and the FDA rejected Amyvid last March.
There is currently no cure for Alzheimer's, a mind-robbing disease that affects more than 35 million people worldwide and gets worse with age.
But an early hint that something is wrong might improve the success of drugs meant to prevent or delay disease progression, researchers believe.
Avid has been in the lead in the race for imaging agents for Alzheimer's, which are estimated to have a potential global market anywhere from $1 billion to $5 billion.
Lilly, as well as Pfizer Inc, are the farthest along in developing experimental medicines to treat Alzheimer's. Lilly expects to release final data for its contender, solanezumab, as soon as this summer.
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