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.

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.

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.

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.

Vivus Inc, the pharmaceutical company responsible for Qnexa, has announced that the Food and Drug Administration’s (FDA) decision on their weight loss drug is pending and to be released on July 17^th. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) has set a date for an oral hearing this September. Vivus also informs us that if they are approved by the FDA, they will be looking to market the product later this year.

Qnexa is made from low dose phentermine and topiramate, which have the combined effect of decreasing appetite and increasing the feeling of satiety. Clinical trials have gleaned very positive results, comprising substantial weight loss and all the health benefits that accompany that, including better management of blood sugar levels. Clearly, a healthy lifestyle must be maintained and a healthy diet adopted to maximise the benefits of the medication. We imagine that on July 17^th, Vivus will be leaving the FDA after receiving a nod of approval. We will update our news pages as soon as a decision has been made.

We have heard that the FDA has delayed its final verdict on Qnexa until July. We do not think that this decision should be viewed in a negative light. All of the signals are that Qnexa will be approved by the FDA. There are even rumours going around that they are under pressure to approve an anti-obesity medication and, as Qnexa is the most effective (and potentially the safest), then this would be the one to go for.

The reason for the delay is quite simple. The FDA has only just received the Risk Evaluation and Mitigation Strategy for Qnexa and they want time to consider it properly.

We are still of the view that Qnexa will be licensed in the US and Europe in 2012. This of course leaves open the possibility that Lorcaserin will be approved before Qnexa. Lorcaserin is less effective than Qnexa in term of weight loss achieved and there are some vestigial concerns about side effects given that it is from the same family of compounds as Fenfluramine, which had to be withdrawn a few years ago because of heart valve damage. Both may get the green light but if we had to choose just one, we would go for Qnexa.

It was announced last week that the advisory panel to the Food and Drug Administration (FDA) has recommended approval to market Qnexa as the latest weight loss treatment for obese patients. Vivus, the pharmaceutical company responsible for the drug, must be quietly confident as the deadline for the FDA’s final decision approaches and what’s more, the votes came in at 20 to 2 from the advisory panel. This is exciting news for Vivus considering the FDA tends to go with the recommendation of the panel, even if they are not bound to do so. The FDA will make their decision on 17^th April so we will be updating you shortly about the Qnexa’s success stateside.

The pharmaceutical company also submitted an application to market Qnexa in Europe in 2010. To date, there has been no news since the application was filed, although if the drug is approved in the States, it looks more likely to be marketed here in Europe after it gets the approval of the European Medicines Agency. While there have been no formal announcements from the European Medicines Agency regarding Qnexa, we have heard that a statement will be issued in the next few weeks.

In other diet pill news, it is believed that Arena will file a marketing authorization application with the European Medicines Agency tomorrow (2 March 2012) for Lorcaserin, a medication that has shown less promise than Qnexa but still meets the minimum weight loss requirements for approval. We will keep patients posted on any progress.

Vivus has completed its analysis of past data relating to Topiramate, one of the ingredients in its proprietary weight loss medication, Qnexa. The study has shown that Topiramate can double the chances of a child being born with a cleft palate or cleft lip if the mother had taken Topiramate during the first trimester of pregnancy compared with mothers who had taken Topiramate in the past but not during pregnancy.

There was a suspicion that Topiramate was linked to this deformity so this is not a huge surprise. The incidence is quite low at 0.36 per cent compared with 0.16 per cent in the mothers who had taken Topiramate in the past but this is statistically significant and will weigh on the decision of regulators.

It seems likely that the FDA will approve Qnexa for patients who are male or who are not of child bearing age. If this does happen then it is entirely likely that Qnexa will be prescribed off-label for women of child bearing age so long as they take every precaution not to become pregnant.

Of all the new weight loss drugs currently being considered, Qnexa seems to have the most impressive weight loss record. If Qnexa gets the go-ahead from the European Medicines Agency then we would be very keen to prescribe it as there is a massive gap in the market for a medication that can suppress the appetite and prolong satiety (the feeling of being full).