Lorcaserin, the new weight loss drug that has been approved by the US Food and Drug Administration (FDA) and recently categorised by the Drug Enforcement Administration (DEA) under the name of Belviq©, is not likely to be sold in Europe any time soon. This is due to the fact that Arena Pharmaceuticals has decided to withdraw the application made to the European Medicines Agency (EMA). The EMA seemed in fact reluctant to introduce the new weight loss pill in Europe and had recently asked for further detailed product information from the company, extending the process necessary to place the medication onto the European market. Clearly Arena was expecting a negative opinion and decided that a dignified withdrawal was preferable. This is very disappointing, given that lorcaserin is expected to soon be sold in the United States and has been thoroughly tested in clinical trials. However, the EMA has had a history of being reluctant to accept applications to market new weight loss medications. That was the case for Qsiva, Vivus’ obesity pill rejected in the last few months. Further information on this will be reported in due course. In the meantime, we await Swissmedic’s decision, Switzerland’s Agency for Therapeutic Products, which is expected in the summer.

The new weight loss drug Belviq© just got a step closer to being available to prescribe in the US. The medication had been approved by the US Food and Drug Administration (FDA) last June: however, Arena Pharmaceuticals was waiting for the Drug Enforcement Administration (DEA) to classify Belviq. Finally, yesterday the drug has been classified as a schedule IV drug (i.e. with low prospective of abuse).

The sale of this medication is therefore scheduled to begin 30 days after publication in the Federal Register, which happened yesterday (8 May 2013).

This medication will be available to overweight and obese individuals to help reduce the body weight, along with a healthy and correct nutrition. The active ingredient of this medication is lorcaserin. The details of how the medication works are still unknown: however what it is known is that the substance activates selectively certain serotonin 2C brain receptors and therefore changes the perception of satiation of the patient. Therefore the individual feels full faster. Side effects of the drug include fatigue, somnolence, impairment of memory and confusion. Therefore patients should be monitored by a doctor especially when starting the first cycle of medication.

We want to highlight that this medication has just been approved in the United States and not in Europe. An application has been filed in the EU but no decision has yet been made.

As we correctly predicted, Lorcaserin has won the vote of the Food and Drug Administration’s (FDA) advisory committee. Since the FDA usually goes with the advice of its panel and considering the vote swung in favour of the drug by 18-4 with one abstention, it looks likely that the approval will go ahead. Lorcaserin will be marketed as Lorqess.

It was said that Lorcaserin’s benefits outweighed the risks and the committee was happy with what it heard in relation to previous anxieties regarding heart valve damage and tumours in rats.

We expect to hear back from the FDA this June and we also anticipate that the European Medicines Agency will approve the drug by the end of 2012, following what we expect to be an approval in the States. EMA accepted the drug’s marketing authorisation application in March this year.

The drug will be manufactured by Arena pharmaceuticals in a plant in Switzerland and distributed and marketed by Eisai. We are keen to start prescribing this medication given the burgeoning problem of obesity and the paucity of options available to patients for whom diet and exercise simply do not work.

There is much buzz surrounding Lorcaserin in advance of 10^th May, the day that the members of a key advisory panel to the Food and Drug Administration (FDA) in the USA voice their opinions on the new weight loss drug. The trade name of Lorcaserin will be Lorqess. The FDA often goes with the decision of its advisory committee but is not obliged to do so, so tomorrow will be an important day for Arena Pharmaceuticals, the pharmaceutical company behind Lorcaserin; especially as this will be the second time they will have stood before the committee attempting to get approval for this drug.

The main focus will be on the pharmaceutical company addressing the safety issues outlined by the committee the last time that Lorcaserin was considered. The concerns included fears over tumours found in rats and the potential for heart valve damage.

We are not too worried about speculation surrounding tumours that were found in rats considering the benign tumours were found in rats during clinical trials and not in humans. The benign tumours are known as fibroadenomas and among rats, are in fact very common anyway whether or not Lorcaserin is administered. Fears over the growth of tumours in humans are unnecessary and are not backed up by clinical trial evidence. We think it highly unlikely that Lorcaserin will stubble over this issue.

The risk of valvulopathy (heart valve damage) was another cause for concern. Years ago, the association between this condition and the weight loss drug fenfluramine, was the reason that the drug was taken off the market in 1997. The FDA is naturally wary, as Lorcaserin comes from the same family of molecules as Fenfluramine. The pharmaceutical company was required to carry out periodic heart scans on the patients during clinical trials to demonstrate that valvulopathy was not a concern.

The company did not observe any increase in the incidence of valvulopathy during clinical trials although the observed levels in the study population was 1.7% against a population incidence of around 2.5%. This may have an impact on the ability to meet the benchmark set by the FDA but the key observation must be the zero increase in incidences.

Possibly of greater concern will be the overall efficacy of Lorcaserin. Although it does meet the FDA’s own benchmark for weight loss drugs, the weight loss is not spectacular overall. However, some patients are high responders and the low responders can be identified at 30 days so treatment can be ceased if the response is lower than would be considered acceptable on a risk benefit analysis.

We have a feeling that Lorcaserin might just make the cut this time although we do not think that it is a sure fire winner because of the low overall response rate.

Arena, the pharmaceutical company responsible for weight loss drug hopeful, Lorcaserin, might yet be the first weight loss drug treatment to be approved by the Food and Drug Administration (FDA) since Orlistat was licensed as the agency has delayed proceedings with the approval of Qnexa for three months. But will Arena have done enough to convince the FDA that Lorcaserin is safe enough to put on the market?

The pharmaceutical company is hoping that the agency will approve Lorcaserin, which will be marketed as Lorqess, despite the meagre 3% difference in weight loss reported between it and the weight loss reported among the placebo control group in phase III clinical trials. However, Lorcaserin did reach the minimum weight loss requirements in that participants lost 5% or more of their original body weights in year one.

It is said that the new drug application submitted by Arena included an explanation regarding the drug and tumours found in rats that had been administered with the drug during animal trials. So, if the panel and the FDA are happy with what the pharmaceutical company has produced in the way of disproving previous concerns regarding the drug’s potential side effects, then the agency may let this one through. We have not seen the details of the explanation relating to the tumours identified in rats but this would not be the first medication that had this effect on rodents but not on humans – we are diffident species after all!

An advisory panel meeting will take place on May 10^th and we are set to hear about whether or not the drug is approved on June 27th. We will update after the advisory panel has reported next week.

The European Medicines Agency (EMA) has accepted the submission by Arena Pharmaceuticals of their Marketing Authorisation Application for Lorcaserin. This does not mean that Lorcaserin is approved, it simply means that all the information that the agency requires has been submitted and the application is in order. It will be months before we hear anything again from the EMA.

If Lorcaserin is approved, in order for a patient to be prescribed this weight loss treatment, they must be either obese or overweight with one weight related co-morbid condition. Lorcaserin targets the area in the brain that controls appetite and clinical trials shown modest but satisfactory results in terms of weight loss. There were other improvements such as lower blood pressure and heart rate that can be associated with weight loss in any event.

In America, the pharmaceutical company submitted a New Drug Application to the Food and Drug Administration at the end of 2011 and news is expected on that front come the end of June, 2012. Arena has had to provide additional information to the FDA and we expect this one to go through given the burgeoning weight problem and the dearth of pharmaceutical intervention tools.

As we trailed in our blog yesterday, Arena Pharmaceuticals has filed a New Drug Application (NDA) with the European Medicines Agency (EMA) for their weight loss treatment, Lorcaserin. Arena does not yet know if the agency will accept the filing of its application but will find out later this month. We understand that Lorcaserin will be marketed as Lorqess.

The drug will be suitable for those who are overweight and have a BMI of over 27 and who have one or more co-morbid conditions as a result of their overweight status and those who are clinically obese with a BMI of over 30.

The company submitted an NDA to the Food and Drug Administration (FDA) some months ago and it was accepted. We are set to have an update on its progress with the FDA this June. Having had their NDA rejected in 2010 by the FDA based on the fact that tumours were reported during animal studies, the pharmaceutical company has conducted further studies to demonstrate the safety of this product. Unlike Qnexa, which is also being scrutinised by the EMA, Lorcaserin is an entirely new molecule so there is no track record outside the sphere of the clinical trials.

Arena Pharmaceuticals must be very pleased with themselves since their application for weight loss treatment, Lorcaserin, was resubmitted and accepted by the Food and drug Administration in the US. The company has also completed a new round of fundraising, which amounted to $33 million.

The original New Drug Application for Lorcaserin had been rejected in 2010. The company has provided further information to the regulator in accordance with its requests regarding concerns that tumours were observed in animal studies. The company’s response to the regulatory body included certain results from their phase III trial, which had not been detailed in the previous application and which outlined study material on the use of Lorcaserin with type-2 diabetes patients.

It is anticipated that the FDA will give a final opinion on Lorcaserin on 27^th June 2012. Meanwhile, we understand that Lorcaserin will be submitting an application to the European Medicines Agency in the next few months.