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New diet drug Qsymia may be rejected by European drug regulators

Qsymia, first diet drug to be approved in 13 years by the U.S. Food and Drug Administration (FDA), may not get clearance from the European Medicines Agency because of the potential for heart problems. A European Union advisory panel is expected to rule on the weight loss treatment sometime next month, but the drug’s maker Vivus Inc. says it has been getting some cold vibes from the group. If rejected, Vivus says it will file a new marketing application or appeal the decision. Vivus wants to market Qsymia in Europe under the name Qsiva. This summer, the FDA approved Qsymia ... Read More

Qsymia makers worry generics may take bite out of profits

Makers of the new obesity drug Qsymia have significantly scaled back their profit expectations after concerns that doctors may prescribe the drug’s ingredients separately rather than the drug itself. Vivus Inc., had estimated profits of as much as $3.6 billion per year, but scaled back its estimate to $1.2 billion, causing Vivus shares to tumble 7.7 percent earlier this week. Qsymia was one of two new long-term diet drugs approved by the Food and Drug Administration (FDA) earlier this year, making the drugs the first weight loss medications to be approved in 13 years. Qsymia was thought to be the ... Read More