FDA ap­proves Idor­sia’s high blood pres­sure drug for pa­tients who need oth­er op­tions

The FDA on Tues­day ap­proved Idor­sia’s new treat­ment for pa­tients with high blood pres­sure who aren’t ad­e­quate­ly treat­ed by cur­rent med­ica­tions. But the drug comes with a black box safe­ty warn­ing and will on­ly be avail­able through a re­strict­ed pro­gram due to the risk of em­bryo-fe­tal tox­i­c­i­ty.

The ap­proval for aproci­ten­tan, which has been brand­ed as Tryvio, comes af­ter John­son & John­son backed away from its part­ner­ship on the drug last year, but the Big Phar­ma will still get roy­al­ties on sales of the drug and 30% of pro­ceeds from any out-li­cens­ing deal.

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