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Vivus Inc. 4 articles

European regulators skeptical about new prescription diet pills

European drug regulators are leery about approving the new weight loss drug Belviq because of safety concerns, including heart valve problems and psychiatric side effects in patients, and tumors observed during studies on lab rats. Belviq is currently under review by an advisory panel for the European Medicines Agency (EMA), which is expected to make a recommendation for the EMA by March whether to approve the drug. Arena Pharmaceuticals, the drug’s maker, has been working with the agency to answer questions and clear up any matters that stand in the way of approval. But its chances may be slim. The ... Read More

Drug company wants to speed review process for new diet drug Contrave

Orexigen Therapeutics Inc. is hoping the Food and Drug Administration (FDA) will grant its request to speed up the review process for its obesity drug Contrave. The agency rejected the weight loss drug in February 2011, saying it needed data from a large-scale study on the long-term cardiovascular effects associated with the medication before approval would be granted. Contrave is a combination of two medications already approved by the FDA – bupropion, which is the active ingredient in the antidepressant Wellbutrin, and the anti-addiction drug naltrexone. Contrave is designed to influence the hypothalamus in order to decrease food intake over ... Read More

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

FDA panel recommends approval of controversial diet drug Qnexa

A new diet drug may soon be available for people battling the bulge, but it may come at a price. This week, a Food and Drug Administration (FDA) advisory panel reviewed clinical data on the weight loss drug Qnexa and voted to recommend its approval despite rejecting its application a year ago due to serious health concerns. The FDA is expected to make a final ruling about the drug later this year, but the agency typically follows the recommendations of its advisory panels. If approved, Qnexa will be the first prescription diet pill to hit the United States market since ... Read More