A new diet pill is angling for approval from the Food and Drug Administration and has many observers waiting patiently to see if the federal agency will allow the weight loss drug NB32 from Orexigen onto the market. It comes as obesity and weight issues remain a top health issue in the United States and across the globe.
Most observers expect the FDA to approve the drug, even as it has in the past put the brakes on untested and unproven weight loss drugs, but the odds appear to be in Orexigen's favor as it has shown that the drug can be used safely, a major FDA concern after a number of other weight loss drugs saw a number of side effects not previously known.
The move for approval comes as Orexigen nearly left the weight loss sector in 2011 after the FDA demanded the company show that safety for the drug was not an issue. The biotech company then invested some $100 million in extra trials before now putting it back to the FDA for approval.
According to reports, Orexigen found 10,000 people for a study to look into the drug further, finding that it was safe and ready for resubmission.
If approved, the company is expected to see massive sales as the US market is ripe for a new weight loss drug that is effective and safe to use.
"Of the three, Takeda has 10 to 15 years' experience in the diabetes marketplace, and that could play to their advantage," Wells Fargo's Matthew Andrews told CNBC's Meg Tirrell. "That, along with 900 reps, could put them in a good position to outperform Street expectations over the next year or so."
But the FDA has been apprehensive in allowing weight loss drugs to flood the market, even as the American Medical Association in 2013 argued that obesity should be treated as a disease, which they said should also include medicine aimed at combatting the growing epidemic.
"Recognizing obesity as a disease will help change the way the medical community tackles this complex issue that affects approximately one in three Americans," said AMA board member Patrice Harris, M.D. "The AMA is committed to improving health outcomes and is working to reduce the incidence of cardiovascular disease and type 2 diabetes, which are often linked to obesity."
Will that be enough to get the FDA on board the new drug? The world will know soon enough.
