|I would think that the FDA asking VVUS to include non-pregnant women implies that they're leaning toward approval.|
From today's WSJ:
JENNIFER CORBETT DOOREN The Food and Drug Administration said Vivus Inc.'s obesity drug Qnexa was effective at helping people lose weight, but the FDA raised concerns about possible long-term side effects such as birth defects and an unknown impact on the heart.
Qnexa is being reviewed by the FDA for a second time after previously being rejected by the agency in 2010. The agency posted a review of Qnexa on its website Friday in advance of an advisory panel meeting on Wednesday. The review of the drug includes two-year clinical data rather than one year's worth of data that was reviewed in 2010.
Qnexa will face the agency's endocrinologic and metabolic drugs advisory committee, which is made up of non-FDA medical experts. The panel is being asked to vote on and discuss a series of questions including whether the "overall benefit-risk assessment" supports approval of Qnexa. The FDA usually follows the advice of its panels but isn't required to.
In 2010 the FDA rejected Qnexa and asked Vivus for an assessment of the drug's potential to cause birth defects and for evidence that the product doesn't increase the risk for major adverse cardiovascular events.
On Friday, the FDA said Qnexa resulted in "significant" weight loss after the first year of treatment with the drug, but noted that patients regained some weight in the second year of the studies. The agency also raised the same concerns as it did in 2010 about a small increase in heart rate and a risk of birth defects.
Other studies of one of Qnexa's ingredients, topiramate, have suggested an increased birth-defect risk. The FDA said exposure to topiramate in pregnancy "is likely to be associated with a two- to fivefold increased prevalence of oral clefts," a defect of the mouth that can be later treated with surgery.
Vivus initially proposed limiting use of the drug to men, as well as women of nonchild-bearing age. But Vivus said the FDA asked the company to develop a plan to limit use by pregnant women. Vivus, in a document also posted on the FDA's website, said Qnexa produces durable weight loss, which "can be expected to contribute greatly toward ameliorating some of the consequences of obesity and weight-related [illnesses]."