As re­sis­tance to stan­dard an­tibi­otics grows, Red­Hill's H. py­lori reg­i­men se­cures FDA ap­proval

In 2017, the WHO des­ig­nat­ed clar­ithromycin-re­sis­tant H. py­lori, a bac­te­r­i­al in­fec­tion that af­fects more than half of the glob­al pop­u­la­tion, a high pri­or­i­ty for an­tibi­ot­ic re­search and de­vel­op­ment. On Mon­day, Is­rael’s Red­Hill Bio­phar­ma se­cured FDA ap­proval for its ri­fabutin-based reg­i­men to ad­dress the alarm­ing rates of re­sis­tance to stan­dard-of-care ther­a­pies.

The new drug will be mar­ket­ed as Tal­i­cia, and the com­pa­ny says it plans a launch in the first quar­ter of 2020. The ther­a­py is an oral cap­sule com­pris­ing ri­fabutin, amox­i­cillin and a pro­ton pump in­hibitor, omepra­zole, and was test­ed in two late-stage tri­als, ERAD­I­CATE Hp and ERAD­I­CATE Hp2.

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