The RAPS store will be under maintenance Saturday, 29 February between 6 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

Regulatory Focus™ > News Articles > FDA Approves Vivus' Obesity Weight Loss Drug Qsymia

FDA Approves Vivus' Obesity Weight Loss Drug Qsymia

Posted 18 July 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) on Tuesday, 17 July approved Vivus Inc's Qsymia, formerly known as Qnexa, for the treatment of obesity. The drug's approval marks FDA's second diet drug approval in as many months after a 13-year drought during which no diet drugs were approved by the agency.

The agency said the drug, a combination of phentermine and topiramate extended-release, is intended for the treatment of adult with a BMI of 30 of greater, or 27 of greater with at least one weight-related health condition. Qysmia's indication is nearly identical to that of Arena Pharmaceuticals' Belviq (lorcaserin hydrochloride), approved on 27 June 2012 by FDA.

The two drugs also share similar safety concerns, including contraindications for pregnant women and some cardiovascular concerns. Unlike Belviq, Qysmia was approved with a Risk Evaluation and Mitigation Strategies (REMS) plan requiring the inclusion of a medication guide and "prescriber training and pharmacy certification."

Vivus will also be required to conduct ten postmarketing studies-four more than Arena-to more fully assess the drug's safety profile as it relates to cardiovascular outcomes. Diet drugs have long been associated with cardiovascular issues, including the infamous diet drug fenfluramine/phentermine (fen-phen), which was taken off the market after being strongly associated with heart valve problems and pulmonary hypertension.

The approval was not without some last-minute controversy, as an article by USA Today broke a media embargo on releasing information related to the drug's imminent approval on 17 July.  The FDA did not formally approve the drug until late in the evening, leading to a period of time in which it was unclear whether the drug had received approval.

Read more:

FDA approves weight-management drug Qsymia

Regulatory Focus newsletters

All the biggest regulatory news and happenings.