Vivus has been pushing for more than two years to get its new obesity drug cleared for sale by the FDA, and after one last long, confusing day, it finally got its wish.
The FDA said today that the Mountain View, CA-based company (NASDAQ: VVUS) has gotten the green light to start selling the combo of phentermine and topiramate (Qsymia) as a new drug to help people lose weight, in addition to diet and exercise. The drug is cleared for obese people, who are defined as having a body mass index (BMI) of 30 and up, or for those who have a body mass index of 27 and up who have at least one other obesity-related health problem, like high blood pressure, type 2 diabetes, or high cholesterol. The average adult man who’s 6 feet tall would have to weigh 221 pounds to be considered obese by the first definition.
“Obesity threatens the overall wellbeing of patients and is a major public health concern,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in an FDA statement. “Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management in Americans who are obese or are overweight and have at least one weight-related comorbid condition.”
The news came after a long day of speculation about FDA approval, as USA Today prematurely published a story about the FDA action before the agency or the company had made an official announcement—an embarrassing snafu that Ron Leuty of the San Francisco Business Times summed up here. The resulting confusion helped drive Vivus stock down 7.8 percent to $26.46 at today’s close.
The drug, formerly known as Qnexa and now pronounced like kyoo-sim-ee-uh, showed in clinical trials that it helped obese patients lose about 10-11 percent of their body weight after a year, compared with about 2 percent weight loss for those on placebo. Dry mouth, tingling of hands and feet, dizziness, insomnia, and constipation were the most common side effects, although the FDA has previously held up Vivus’ marketing application over questions about a link between the drug and birth defects.
Now that the FDA has said the benefits of the drug outweigh the risks, Vivus can finally start selling a drug, 31 months after submitting its first application to the agency. The sales opportunity is huge, as an estimated two-thirds of Americans are now overweight or obese, raising their risk for a range of related ailments, including diabetes, heart attack, stroke, depression, and arthritis. Big Pharma companies have mostly shied away from treating obesity the past decade in the wake of the multi-billion legal liability that came from the fen-phen combo drug debacle, in which a weight loss drug from Wyeth was linked to damaged heart valves. Getting the FDA’s clearance to enter this market means that Vivus will now compete against another new entrant into the obesity drug world, San Diego-based Arena Pharmaceuticals (NASDAQ: ARNA) and partner Eisai Pharmaceuticals, which won approval last month to start selling lorcaserin (Belviq).
The Vivus drug should be a strong new competitor in the market, because it’s been shown to help people lose more weight than the Arena/Eisai compound, said Simos Simeonidis, an analyst with Cowen & Co., in a note to clients on June 27. “The anti-obesity space has the potential to be a large market, with multiple lines of therapy, since most patients will probably either not respond or not achieve the desired weight loss, and will thus end up trying more than one agent,” Simeonidis wrote.
There are a number of strings attached to today’s approval that investors will surely mull over before trading starts again tomorrow. The FDA approval comes with a Risk Evaluation and Mitigation Strategy (REMS), which requires doctors to carefully walk through the risks of the drug with patients before prescribing it. The REMS plan calls for doctors to discuss “increased risk of birth defects associated with first trimester exposure to Qsymia, the need for pregnancy prevention, and the need to discontinue therapy if pregnancy occurs,” according to the FDA statement. The Vivus drug is also known to increase heart rate, and the FDA said it recommends regular monitoring of patients’ heart rates, especially when starting Qsymia or raising the dose. The company is also required to meet 10 post-marketing commitments, including a long-term clinical trial to assess whether the drug causes an increased risk of heart attack or stroke.