FDA通過Arena Pharmaceuticals 新減肥藥/ Vivus Inc and Orexigen Therapeutics 等候中 !!

（中央社華盛頓/紐約27日綜合外電報導）美國食品暨藥物管理局（FDA）睽違13年，今天首次通過名為lorcaserin的減肥藥，商品名為Belviq。 公衛人士推動解決美國益發嚴重的肥胖問題之際，FDA通過艾瑞納製藥（Arena Pharmaceuticals Inc）的上市核可。 儘管FDA知道數百萬美國人對於減肥藥躍躍欲試，但基於安全問題以及過去藥物致死病例，因此設下超乎尋常的高門檻。最惡名昭彰的是1997年下架的減肥藥「芬芬」（fen-phen）。 但鑑於2/3美國人體重過重或肥胖，造成的公衛與經濟支出攀升，FDA通過新減重治療的壓力也日增。 Lorcaserin會影響大腦受體，達到控制食慾的效果。經FDA核可適用於特定過重與肥胖病患，為配合飲食與運動的額外治療。 FDA表示，根據臨床試驗，試驗對象使用lorcaserin 1年後，比起安慰劑平均能減下3%到3.7%體重。lorcaserin適用於身體質量指數（BMI）30以上的肥胖成人病患，或是BMI27以上、至少有其他1種病症的成人病患，如高血壓、第2型糖尿病或高膽固醇。不過FDA表示，艾瑞納製藥必須進行6個後續研究，其中包括Belviq是否增加心臟病發作與中風風險的長期研究。 核可消息傳出後，艾瑞納製藥股價開盤時飆高47%，達到每股9美元。艾瑞納製藥表示，公司正尋求通過歐洲市場核可，但尚未定下時間表。（譯者：中央社陳怡君）1010628  

Consumer group urges FDA to reject Arena diet drug By Susan KellyTue Jun 26, 2012 5:48pm EDT(Reuters) - Watchdog group Public Citizen urged U.S. regulators on Tuesday not to approve Arena Pharmaceuticals Inc's experimental diet pill lorcaserin, citing concerns it could increase patients' risk of heart valve damage.The U.S. Food and Drug Administration is expected to rule on whether to approve the drug by Wednesday.Public Citizen, a nonprofit consumer advocacy group, said physicians at last month's FDA advisory panel meeting on lorcaserin raised serious concerns about evidence of increased valve disease risks in patients who used the drug in clinical trials. The panel of independent experts voted 18 to 4 to recommend approval of the pill despite the concerns.If approved, lorcaserin would become the first new diet drug on the U.S. market in more than a decade. Heart valve problems were among the issues that led FDA to pull the anti-obesity drug known as fen-phen from the market in 1997, Public Citizen said.The group also noted that FDA's panelists were concerned about the modest weight loss associated with lorcaserin. A spokesman for Arena declined to comment on Public Citizen's concerns and said the company is focused on preparing for the FDA decision. An FDA spokeswoman declined to comment and said the agency would respond directly to Public Citizen. Arena's pill is one of three new potential obesity treatments vying to gain U.S. approval. Vivus Inc and Orexigen Therapeutics Inc are also trying to get pills approved.Vivus in February won backing for its pill Qnexa from the same advisory panel that voted in favor of lorcaserin. The FDA pushed back its final decision on Qnexa to July 17 to review the company's risk evaluation plan for the drug.The FDA first rejected lorcaserin, which is being developed in partnership with Japanese drugmaker Eisai Co Ltd, in October 2010, citing potential cancer risks. Arena resubmitted its application with more data to show that the previous findings of tumors in rats did not apply to people.At the May advisory meeting, most panel members said side effects from lorcaserin could be addressed in post-approval studies and suggested patients who take the drug should get regular echocardiograms.The panelists said overweight and obese patients needed more options.Arena's lorcaserin was designed to block appetite signals in the brain in a similar way to fen-phen. Another diet pill, Meridia, was withdrawn in 2010 after also being linked to heart problems.Arena's stock plunged 15 percent last Friday in what some traders attributed to profit-taking ahead of the FDA's decision. At one point during the day it had shed a third of its value. The stock has appreciated more than 400 percent this year in anticipation of a favorable ruling.