My webmaster tells me that we have had a record number of visitors to our website this week. Thank you all for visiting us. I suspect many of you were looking for some last minute comments before the June 27, 2011 PDUFA Date for lorcaserin. I didn’t post anything because I had nothing new to add. As I had said in the past, I thought Arena (ARNA) had a better chance of getting approval for LORQESS than did Qnexa because the cardiac problems could be monitored and managed while the teratogenicity issue with Qnexa was binary, ie, all or nothing on the teratogenic effect.
Well, Arena is rejoicing and ringing the BELVIQ! (nee LORQESS). The folks at Vivus (VVUS) and probably some of the analysts are seeing the BELVIQ approval as a sure sign that an approval for QNEXA is just around the corner. I say not so fast. If you remember, a major concern expressed here and raised by some at the Advisory Committee meeting was whether women of child bearing potential who were overweight would heed the warning to avoid getting pregnant, especially in light of the number of women in the QNEXA controlled clinical trials who became pregnant.
Well, those clever folks at FDA added a couple of things to the BELVIQ approval that might do two things. The first is a warning that women of child bearing potential should not take BELVIQ. If I were FDA, I’d try and find a way to monitor how many women and their physicians paid attention to that warning. Should be relatively easy to collect that information. If they find a significant pregnancy rate in women taking BELVIQ, they know the warning is not enough – all this done without jeopardizing an unborn child. The second thing that the FDA did was to recommend that the DEA assign a control classification to BELVIQ. Whether the DEA will do this is unknown at this time. If they do, there is a made to order distribution control for QNEXA should they decide to do it.
If your looking for the bottom line that I normally provide, this is it – if I had to lose 40 pounds in 2 years and had only the choice of waiting for QNEXA or diet, I’d start giving up the cupcakes tomorrow!
Those of you who read our Special Report on Diet Drugs got a heads up on both the extension of the QNEXA PDUFA Date and the easy time that LORQESS had with the FDA Advisory Committee last week. But now it’s crunch time and the folks at Vivus and Arena Pharmaceuticals are supplementing their diets with fingernail sandwiches. Arena has the shorter wait at this time, June 27, 2012 is still their PDUFA Date for LORQESS. By virtue of the extension, Vivus has to wait until July 26, 2012.
Neither the FDA nor the Advisory Committees have questioned the efficacy of either drug. Neither set of reviewers have tried to say one is more efficacious than the other. I agree and would call them equally efficacious.
Both drugs have reported or perceived cardiovascular side effects. According to the Advisory Committee earlier this year, such drugs should be required to have cardiovascular studies performed before approval. However, both drugs were submitted for approval and under review when the recommendation, and it is only a recommendation, by the Advisory Committee was made. That being said, the FDA has a certain degree of leeway in forcing this requirement as an approval requirement. In my opinion, the FDA will give both companies a break and allow the required study to be done as a condition of approval. It will be the most closely watched event since the OJ trial. One might think that QNEXA has the leg up on this because they went to the Advisory Committee first, but in this case, one would be wrong. Both companies got the information at the same time – from listening to the Advisory Committee live and in person. Who has the edge on having the protocol in final form? I don’t know and neither does anyone else except maybe the FDA and I heard they ain’t talking.
FDA doesn’t have to talk about the cardiovascular protocol race because the race isn’t about the cardiovascular side effects, its about the teratogenicity risk. FDA is breathing a sigh of relief with the data from Arena and the positive vote from the Advisory Committee for LORQESS. The pressure is off – they have a viable diet drug alternative to QNEXA to satisfy those screaming for a new drug. And they have an alternative that is not a teratogen. Even if LORQESS gets an extension of the PDUFA Date from FDA to tidy up their cardiovascular study protocol, they will still be ahead of Vivus who has a somewhat longer struggle with the teratogencity issue.
Arena Pharmaceuticals has submitted information on their one year study of LORQESS (lorcaserin) to the FDA to support their NDA application for the drug in treating obesity. We, as well as others have provided opinions on the likelihood of Arena being successful, the Advisory Committee did not recommend approval and the FDA has not approved LORQESS. Yet, Arena keeps trying.
The new one year data provide some additional information on the efficacy that still isn’t enough to convince me that the drug is at least meeting the minimum requirements of the FDA Guidelines for Obesity Drugs. I can’t even say that the results are marginal. At the end of a year, LORQESS patients showed a 4.5% weight loss from baseline compared to a 1.5% weight loss for placebo patients.
By far, the most alarming data in the one year study are the reports of study patients who showed heart valve problems. The LORQESS patient group reported 2.9% of patients with heart valve problems vs. only 0.5% reported for the placebo group.
Doesn’t anyone at Arena remember all the heart valve problems with diet drugs 10 years ago? C’mon, somebody take the shovel away from them – the hole is deep enough already!