The Food and Drug Administration in the USA has accepted Vivus’s new drug application for the approval of their obesity drug, Qnexa, which will assist with weight loss in obese patients with a BMI of greater than 30 or patients who are overweight with a BMI of greater than 27 and with other health complications that stem from their weight. The FDA has set a target date of the 17th April of next year for this application.
The treatment will also be suitable for patients who suffer from illnesses or conditions associated with their weight such as type-2 diabetes. The drug is not suitable for women of a childbearing age at the current time, pending further investigations to ascertain whether there is an association between topiramate and birth defects. The application will be discussed in the first quarter of next year.
Qnexa is now the closest weight loss drug to the finish line. This is an exciting time for Vivus, which has been hoping to have their phentermine/topiramate combination on the market for some time now. The pharmaceutical company also submitted a marketing authorization application with the European Medicines Agency in 2010. A decision is expected at the end of this year on this matter. Given the dearth of treatment options available, there is a dire need for some sort of medication to give patients the help that they need to get the weight off. The questions will be whether they can keep the weight off after they come off the medication.