Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The sto­ry of Am­ryt Phar­ma’s can­di­date for the ge­net­ic skin con­di­tion epi­der­mol­y­sis bul­losa, or EB, will soon en­ter an­oth­er chap­ter.

Af­ter the Irish drug­mak­er’s can­di­date, dubbed Oleogel-S10 and mar­ket­ed as Fil­su­vez, was hand­ed a CRL ear­li­er this year, the com­pa­ny an­nounced in a press re­lease that it plans to sub­mit a for­mal dis­pute res­o­lu­tion re­quest for the com­pa­ny’s NDA for Oleogel-S10.

Ac­cord­ing to the com­pa­ny, it re­cent­ly had a meet­ing with the FDA to dis­cuss the is­sues raised in the Feb­ru­ary CRL. The biotech ini­tial­ly re­port­ed that the FDA de­mand­ed “ad­di­tion­al con­fir­ma­to­ry ev­i­dence of ef­fec­tive­ness for Oleogel-S10 in EB.”

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