Waiting For Arena, Thoughts On Meridia

Today the second of three potential drugs in the weight-loss race is in the hot seat- Arena Pharmaceuticals' lorcaserin, which we recently learned will be called Lorqess, if approved. An FDA panel is meeting to decide whether it will recommend the drug for approval. I'm following two liveblogs of the panel, from Lisa LaMotta of Minyanville and Adam Feuerstein of TheStreet.com, and will post my thoughts on the aftermath tomorrow. Obesity drug watchers are looking for clues about today's panel based on one that happened yesterday- that was when Abbott Laboratories' obesity drug Meridia, on the market since 1997, came under FDA's microscope. Meridia works by blocking reuptake of the neurotransmitters serotonin and noradrenalin in the brain, leading to a decrease in appetite. It's effective at helping patients shed pounds, but the drug also boosts blood pressure and heart rate. So doctors and patients have had to deal with a tradeoff between weight loss efficacy and safety (this theme seems to come up a lot in the obesity drug field). Things shifted last November, when a large study called the SCOUT trial suggested that patients on sibutramine had more cardiovascular events compared to patients on placebo. As this WebMD article puts it:
The drug is already not supposed to be used in patients with known cardiovascular disease. But experts said they were troubled that many patients with undiagnosed disease could be at greater risk if they use the drug to lose weight.
In the aftermath, sibutramine was pulled from the market in the UK and other European nations. And stateside, concern mounted. Which brings us to yesterday's panel. The panel vote was split as to whether to keep sibutramine on the market. Of 16 panelists, 8 voted to withdraw the drug, 2 voted to keep it on the market with more strict warning label language, and 6 voted to keep it on the market with label revisions and restrictions on which doctors can prescribe the drug. (Hat tip to Shelley Wood at theheart.org for getting the vote results up on Twitter asap). So in short, it's not clear to me what will become of Meridia. As for whether the Meridia panel outcome will affect the Lorqess panel today, Leerink Swann analyst Joshua Schimmer wrote in a note to investors that FDA's safety concerns for lorcaserin/Lorqess are likely to be different than the concerns about sibutramine/Meridia. "Because lorcaserin drops both heart rate and blood pressure (albeit in a non-statistically significant manner), we believe the CV issue will not be a major issue," he wrote. But FDA's briefing documents for Lorqess had a safety surprise, which Schimmer says may come into play. The documents raise questions about about malignant tumors that occurred in rats treated at high doses of lorcaserin. Arena's stock plummeted in response to the briefing documents, which were released on Tuesday. You can read Derek Lowe's take on the tumor situation here. I've been saying that Arena's had to do its due diligence on cardiovascular safety, but I'll admit I know very little about this other safety-related situation. Stay tuned.

Author: Carmen Drahl

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  1. Abbott Takes Diet Drug Meridia (Sibutramine) Off The Market | The Haystack - [...] pulled from the market in the UK and other European nations earlier this year. You can click here to…