FDA re­views com­ing out on 3 new obe­sity drugs

Austin American-Statesman - - WORLD & NATION - By Matthew Perrone

WASHINGTON — Di­eters, doc­tors and in­vestors get their first ex­ten­sive look at the first of a trio of new weight loss drugs this week. The hope is that the new drugs can suc­ceed where many oth­ers have failed: de­liv­er­ing sig­nif­i­cant weight loss with­out risky side ef­fects.

With U.S. obe­sity rates near­ing 35 per­cent of the adult pop­u­la­tion, ex­pec­ta­tions are high for the first new pre­scrip­tion drug ther­a­pies to emerge in more than a decade. Even a mod­estly ef­fec­tive drug has block­buster po­ten­tial.

None of the three medicines rep­re­sents a break­through in re­search. Drug­mak­ers have made lit­tle head­way in un­der­stand­ing and treat­ing the causes of overeat­ing. Two of the drugs sub­mit­ted for ap­proval sim­ply com­bine ex­ist­ing drugs, but have wor­ry­ing side ef fects. Qnexa has an an­ti­con­vul­sant and an am­phet­a­mine, and Con­trave mixes an an­tide­pres­sant with an an­ti­con­vul­sant. Lor­caserin is a new med­i­ca­tion, and is safer but less ef­fec­tive.

The quest for a block­buster weight loss drug has been plagued for decades by safety is­sues. The most no­table was Wyeth’s diet pill drug com­bi­na­tion fen­phen, which was pulled off the mar­ket in 1997 due to links to heart valve dam­age and lung prob­lems.

The FDA is ex­pected to post its re­view of Vivus Inc.’s pill Qnexa to­day and will hold a pub­lic meet­ing Thurs­day to re­view the data. Orex­i­gen Ther­a­peu­tics Inc.’s Con­trave is set for re­view in Oc­to­ber, and Arena Phar­ma­ceu­ti­cals Inc.’s lor­caserin is set for De­cem­ber.

To be con­sid­ered ef­fec­tive, obe­sity drugs should re­duce to­tal body weight by at least 5 per­cent af­ter one year, ac­cord­ing to FDA guid­ance to com­pa­nies.

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