The drug developer Vivus Inc got the backing of a U.S. advisory panel as the company aims to gain approval for this new obesity drug in 13 years. Analysts say the drug, if approved, may generate $448 million in sales in 2015. some other drug developers, Orexigen Therapeutics Inc., based in La Jolla, California, and San Diego-based Arena Pharmaceuticals Inc. also are seeking approval for their obesity medicines, which the FDA refused to approve without more data on safety risks.
The US Food and Drug Administration’s Endocrinologic and Metabolic Drug Advisory Committee voted 20 to two that Qnexa’s benefits outweigh its risks at a meeting at agency headquarters in Silver Spring, Maryland. The company’s Qnexa (phentermine/ topiramate) is recommended for obesity in adults
The approval of the new weight-loss pill Qnexa is the good news for Americans with a weight problem. Obesity case shouldn’t be disparaged. Obesity raises the risks of diabetes, heart attacks and stroke. The harms are not only about health, it costs the U.S. economy an estimated $147 billion a year in medical expenses and lost productivity, according to the Atlanta-based CDC.
Qnexa is one of three medications vying for the first U.S. approval of a prescription weight-loss treatment since Swiss drug maker Roche Holding AG’s Xenical in 1999. An advisers meeting in March is prepared to discuss the possibility of requiring hearth-risk studies for all weight-loss drugs. The FDA plans panel members discussed whether Vivus should conduct such a long-term safety study before or after approval. The company is also planned to sell the drug through a limited number of mail-order pharmacies swayed them in favor of supporting the drug despite limited safety data.
“Of all the obesity drugs, this one has the highest efficacy in terms of weight loss, so that shifts the balance in terms of requiring a post-approval study rather than a pre- approval study,” said Sanjay Kaul, a cardiology professor in the David Geffen School of Medicine at UCLA Cedar Sinai Medical Center and a panel member.
Qnexa combines the appetite suppressant phentermine with topiramate, an antiseizure and migraine drug and regulators raised concerns that the medicine may contribute to a greater risk of heart ailments and birth defects.
“We are pleased with the panel’s approval recommendation in support of the safety and efficacy of Qnexa,” said Peter Tam, president of Vivus, adding: “We look forward to working with the FDA as they complete their evaluation. Obesity is a serious medical condition, and we are committed to making Qnexa available and providing physicians with a new medical treatment option in their battle with this public health epidemic.”
Vivus is waiting, the obese is waiting, and public are waiting, whether the obese should be rescued by such a diet in camp or by the weight-loss pills.