FDA OKs Por­to­la’s an­ti­co­ag­u­lant be­trix­a­ban for pre­vent­ing blood clots

Any­one look­ing for a case that the FDA is light­en­ing its stan­dards for new prod­ucts should take a hard look at the agency’s ap­proval for Por­to­la’s be­trix­a­ban to­day.

Last year the com­pa­ny re­port­ed that its an­ti­co­ag­u­lant has just bare­ly failed a key end­point in ex­am­in­ing the drug’s ef­fi­ca­cy (p=0.054) among a key co­hort of pa­tients with el­e­vat­ed D-dimer lev­els. The com­pa­ny went on, though, to do an ex­plorato­ry analy­sis of the re­sults, claim­ing a win in re­duc­ing the risk of ve­nous throm­boem­bolism — or sim­ply, blood clots — for their drug com­pared to enoxa­parin.

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