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by Robert MacKay, Sunday, February 24, 2013 | Categories: Qnexa | Qsiva

Qsiva (formerly known as Qnexa and Qsymia in the US) has been denied a license by the European Medicines Agency following the appeal by Vivus. Vivus (the patent holder) requested a re-examination of the evidence and we believe that they put together a risk mitigation strategy similar to the one used in the US. This, however, did not impress the committee that decides which medications can be marketed in Europe. The committee has raised concerns about potential side effects but the fact is that both of the component medications are licensed in the European Union at the current time and the objections are to the actions of the components on a unilateral assessment; there is absolutely nothing to indicate that the dual therapy produced side effects not associated with the individual active ingredients. The objections are based on potential cardiovascular events related to phentermine and psychiatric side effects related to topiramate.

The evidence coming out of the US (where this medication is licensed as Qsymia) is that this treatment actually improves cardiovascular risk factors in patients who have successfully lost weight. The most recent update showed that patients being prescribed this medication recorded a medically significant drop in systolic blood pressure and a drop in non-HDL blood cholesterol. We continue to believe that for obese patients the benefits definitely outweigh the risks and this view was supported by the Scientific Advisory Group that provides guidance to the committee. The European Medicines Agency however appears to have based its risk assessment on the possibility that Qsiva will be used by patients for whom it is not intended. Surely that is what doctors are for – to make sure that medications are prescribed appropriately.

Medication cannot be the only answer to the obesity epidemic but it is part of the solution and there is a massive unmet clinical need in the EU that the EMA seems to be ignoring. We sincerely hope that Vivus takes this matter to the next level of appeal.

by Robert MacKay, Tuesday, October 23, 2012 | Categories: Qnexa | Qsiva

We previously reported that Vivus Inc did not feel confident about its obesity treatment, Qsiva (previously known as Qnexa) being approved for marketing in the EU. Therefore, we are not surprised to hear that Qsiva has now received a negative opinion from the European Medicines Agency.

Although the drug has been approved by the Food and Drug Administration (FDA) in the US under the name Qsymia, the current denial by the European Medicines Agency has been attributed to several concerns that are being argued to outweigh the benefits of the medication. All of these concerns (cardiovascular and psychiatric side effects) were raised in the US as well, and let us not forget that Qsymia was initially rejected by the FDA. The FDA ultimately got comfortable with the medication following further studies and a meta-analysis of previously published information.

The Committee for Medicinal Products for Human Use seems to have majored on the potential use of Qsiva by people for whom it is not intended but this could be said of many medications. Clearly there must be very strict prescription and supply guidelines for this medication and we believe that Vivus has put forward a risk mitigation strategy similar to the one used in the US.

Despite the negative outcome, Vivus has stated that it will appeal and request a re-examination of the decision. Given the very compelling clinical trial data that we have detailed on the Qsiva product page of our website, we would be very surprised if Qsiva is not ultimately approved for use in the EU. The dearth of effective weight loss treatments available for us to prescribe is very frustrating – both for us as doctors and for patients. It is all very well asking patients to go off and eat a different diet and take a bit of exercise but many have done this and failed. It is our view that the risks associated with Qsiva are more than outweighed by the benefits as far as obese patients are concerned. Our view would be different if we were talking about moderately overweight patients but it is up to doctors to ensure appropriate prescribing.

by Robert MacKay, Tuesday, September 25, 2012 | Categories: Qnexa | Qsiva

Vivus Inc. has announced that they are not feeling very confident about the European Medicines Agency’s decision on their new weight loss drug that has recently been launched in the US under the name Qsymia.

Seemingly the EU committee has been raising concerns over the use of phentermine in this combined drug. Phentermine is generally not supplied anymore in the EU as it is an addictive drug and is thought to cause long term side effects. This drug however contains phentermine on a control release basis, therefore making it safer and probably non-addictive.

We are due to hear more on the potential approval of this drug come October after the European Medicine’s Agency meeting next month. The company is prepared to appeal a negative result or resubmit the marketing application. A negative result would be very disappointing as the efficacy of this medication seems impressive.

by Robert MacKay, Monday, September 24, 2012 | Categories: Qnexa | Qsiva

Qsymia has had its market debut in the US but it is not available in Europe yet. Earlier this year, the FDA vote approving the drug (which contains phentermine and topiramate) was almost unanimous and results from clinical trials were very successful across the board, with patients losing 10% of their original body weight.

With few options left for the treatment of obesity but for invasive weight loss surgeries, this could be a very exciting drug to have on the market in Europe and all going well this will be the case very soon . The European Medicines Agency (EMA) has been talking to Vivus regarding European approval and a decision is due later this year. As we have said before, we anticipate a positive outcome and will be updating this page as soon as we have more news. We expect Qsymia to be called Qnexa in Europe.

by Robert MacKay, Wednesday, July 18, 2012 | Categories: Qnexa | Qsiva

The Food and drug Administration in the US has approved a new weight loss pill. The drug, whose name has been changed from Qnexa to Qsymia (in order to rule out possible confusion with other drugs of a similar name), was approved yesterday and is no doubt a very welcome addition to the sparse range of weight loss treatments available today. At trial stage, patients on average lost 10% of their body weight over 12 months, with many losing considerably more. This will offer many weight loss patients in the States an alternative to invasive and risky surgeries.

It is likely that the pharmaceutical company, Vivus, will meet with the European Medicines Agency (EMA) this coming September. We are expecting a positive outcome and will be surprised if a license in not granted for the EU. Prescribing restrictions may be placed on this medication and we may decide that it is not appropriate for online prescribing. At the moment it looks like we could prescribe online with very strict controls and regular patient contact. We will only be able to make a final decision on this when we have a full response from the European Medicines Agency.

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