Reactions 1320 - 25 Sep 2010 US FDA advisory panel votes against approval for lorcaserin A US FDA advisory panel has voted 9–5 against recommending approval for Arena Pharmaceutical’s obesity agent lorcaserin, citing insufficient efficacy to justify the associated risks of the drug. 1 In a briefing document released prior to the advisory panel’s meeting, the adverse effect profile of lorcaserin was discussed, focussing on the risk of neuropsychiatric disorders, and cardiac valvular insufficiency. 2 However, the document’s executive summary of safety declared lorcaserin to be "generally well tolerated", particularly at the proposed clinical dose of 10mg twice daily, with the most common adverse events reported as headache, dizziness, fatigue, nausea and dry mouth. The summary noted that all these events "tended to be mild or moderate and self-limited", and that none tended to recur during continued dosing "once the initial event had resolved". Approval still on the cards? Analysts at inThought released their research the day before the panel’s vote, and concluded that, based on the risks to approval outlined in the FDA’s briefing documents, lorcaserin had a 74% likelihood of being approved. 3 The analysts believed that, while they anticipated the panel would consider lorcaserin to offer "modest efficacy", there would be "vigorous debate on safety". They say that the briefing documents showed pooled safety data from both BLOOM and BLOSSOM to demonstrate a low incidence of valvulopathy that was similar to placebo, but say that the FDA "is not entirely convinced" that this risk is low enough. The inThought team also noted that the proportion of lorcaserin recipients demonstrating cognitive-, perceptual- or dissociative-related adverse events was "not large in percentage terms". Based on these data, the team continued to model a March 2011 launch for lorcaserin (proposed brandname Lorqess), with global sales reaching $US993 million by 2017, if approved. The FDA is scheduled to convene on 22 October this year to make an approval decision for lorcaserin, and while the agency normally follows its panels’ recommendations, it isn’t required to do so. 1 1. Bloomberg. Arena fails to win U.S. panel’s backing for experimental obesity treatment. Internet Document : [3 pages], 16 Sep 2010. Available from: URL: http://www.bloomberg.com. 2. FDA. Lorcaserin hydrochloride (APD356): NDA 22-529: briefing document for FDA Advisory Committee Meeting. Internet Document : [209 pages], 13 Aug 2010. Available from: URL: http://www.fda.gov. 3. Wiatr C, et al. Lorcaserin’s cancer and neuropsychiatric risks: positive outcome still expected tomorrow. Internet Document : [3 pages], 15 Sep 2010. Available from: URL: http://www.in-thought.com. 801140875 1 Reactions 25 Sep 2010 No. 1320 0114-9954/10/1320-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved

US FDA advisory panel votes against approval for lorcaserin

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Reactions 1320 - 25 Sep 2010

US FDA advisory panel votesagainst approval for lorcaserin

A US FDA advisory panel has voted 9–5 againstrecommending approval for Arena Pharmaceutical’sobesity agent lorcaserin, citing insufficient efficacy tojustify the associated risks of the drug.1

In a briefing document released prior to the advisorypanel’s meeting, the adverse effect profile of lorcaserinwas discussed, focussing on the risk of neuropsychiatricdisorders, and cardiac valvular insufficiency.2

However, the document’s executive summary ofsafety declared lorcaserin to be "generally welltolerated", particularly at the proposed clinical dose of10mg twice daily, with the most common adverseevents reported as headache, dizziness, fatigue, nauseaand dry mouth. The summary noted that all these events"tended to be mild or moderate and self-limited", andthat none tended to recur during continued dosing "oncethe initial event had resolved".

Approval still on the cards?Analysts at inThought released their research the day

before the panel’s vote, and concluded that, based onthe risks to approval outlined in the FDA’s briefingdocuments, lorcaserin had a 74% likelihood of beingapproved.3

The analysts believed that, while they anticipated thepanel would consider lorcaserin to offer "modestefficacy", there would be "vigorous debate on safety".They say that the briefing documents showed pooledsafety data from both BLOOM and BLOSSOM todemonstrate a low incidence of valvulopathy that wassimilar to placebo, but say that the FDA "is not entirelyconvinced" that this risk is low enough.

The inThought team also noted that the proportion oflorcaserin recipients demonstrating cognitive-,perceptual- or dissociative-related adverse events was"not large in percentage terms". Based on these data, theteam continued to model a March 2011 launch forlorcaserin (proposed brandname Lorqess), with globalsales reaching $US993 million by 2017, if approved.

The FDA is scheduled to convene on 22 October thisyear to make an approval decision for lorcaserin, andwhile the agency normally follows its panels’recommendations, it isn’t required to do so.1

1. Bloomberg. Arena fails to win U.S. panel’s backing for experimental obesitytreatment. Internet Document : [3 pages], 16 Sep 2010. Available from: URL:http://www.bloomberg.com.

2. FDA. Lorcaserin hydrochloride (APD356): NDA 22-529: briefing document forFDA Advisory Committee Meeting. Internet Document : [209 pages], 13 Aug2010. Available from: URL: http://www.fda.gov.

3. Wiatr C, et al. Lorcaserin’s cancer and neuropsychiatric risks: positive outcomestill expected tomorrow. Internet Document : [3 pages], 15 Sep 2010. Availablefrom: URL: http://www.in-thought.com.

801140875