Por­to­la caps a prob­lem-plagued year with an ap­pli­ca­tion for an­ti­co­ag­u­lant be­trix­a­ban

Por­to­la $PT­LA has had an aw­ful year so far in 2016. Its an­ti­co­ag­u­lant be­trix­a­ban failed a piv­otal study in March and then the FDA re­ject­ed its close­ly-watched an­ti-an­ti­co­ag­u­lant An­dexxa, de­signed to re­verse an­ti­co­ag­u­la­tion for Fac­tor Xa in­hibitors. But as promised, the biotech is push­ing ahead with an FDA ap­pli­ca­tion on be­trix­a­ban in any case.

The way their study was de­signed for be­trix­a­ban, in­ves­ti­ga­tors had to see a sta­tis­ti­cal­ly sig­nif­i­cant ad­van­tage for their drug arm in a co­hort of pa­tients with el­e­vat­ed D-dimer lev­els—which is used to eval­u­ate pa­tients—in or­der to gain a clear un­der­stand­ing of the ther­a­py’s ben­e­fit in a sec­ond co­hort in­clud­ing old­er pa­tients and then the en­tire pa­tient pop­u­la­tion.

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