Boehringer In­gel­heim's Ofev wins FDA ap­proval for use in scle­ro­der­ma pa­tients

Five years af­ter se­cur­ing its first ap­proval in id­io­path­ic lung fi­bro­sis,  Boehringer In­gel­heim’s drug Ofev has been cleared to slow the rate of pul­monary de­cline in pa­tients with an­oth­er lung scar­ring dis­ease.

The ap­proval — for pa­tients with in­ter­sti­tial lung dis­ease as­so­ci­at­ed with sys­temic scle­ro­sis or scle­ro­der­ma (SSc-ILD) — marks the first FDA nod for the rare lung con­di­tion.

The agency’s en­dorse­ment was based on da­ta from a 576-pa­tient place­bo-con­trolled study. The main goal of the tri­al was to mea­sure lung func­tion via forced vi­tal ca­pac­i­ty (FVC) — de­fined as the amount of air that can be forcibly ex­haled from the lungs af­ter tak­ing the deep­est breath pos­si­ble — at the end of 52 weeks, al­though some pa­tients were treat­ed for up to 100 weeks.

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