FDA adds new 'do not use' note to Intercept's Ocaliva label after a slew of side effect reports in cirrhosis patients - Endpoints News

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In­ter­cept has seen noth­ing but hard times the past year af­ter a high­ly tout­ed swing at NASH fell flat at the FDA’s feet last sum­mer. Now, the drug that In­ter­cept hoped would get over the fin­ish line in NASH is fac­ing new safe­ty flags in an­oth­er in­di­ca­tion, and the FDA is tak­ing ac­tion on its la­bel.

The FDA has added a con­traindi­ca­tion to its la­bel for In­ter­cept’s Ocali­va (obeti­cholic acid) to treat pri­ma­ry bil­iary cholan­gi­tis af­ter a slew of side ef­fects in pa­tients with ad­vanced cir­rho­sis and ear­ly cir­rho­sis pa­tients with ex­ist­ing hy­per­ten­sion in the por­tal vein were re­port­ed to the agency, In­ter­cept said Wednes­day.

The la­bel now ropes off all pa­tients with what’s called “de­com­pen­sat­ed”— or ad­vanced — cir­rho­sis as well as “com­pen­sat­ed” cir­rho­sis pa­tients with por­tal hy­per­ten­sion af­ter re­ports of wors­en­ing liv­er cas­es on the drug.

In­ter­cept not­ed that the new la­bel would not change treat­ment for a “large ma­jor­i­ty” of PBC pa­tients as “most pa­tients with PBC do not have de­com­pen­sat­ed cir­rho­sis, a pri­or de­com­pen­sa­tion event, or com­pen­sat­ed cir­rho­sis with ev­i­dence of por­tal hy­per­ten­sion,” CMO Gail Calk­well said in a state­ment.

The drug, which is ap­proved in the sec­ond line as ei­ther a com­bo with ur­sodeoxy­cholic acid (UD­CA) with an in­ad­e­quate re­sponse to UD­CA or as monother­a­py in pa­tients un­able to tol­er­ate UD­CA, was ini­tial­ly giv­en the FDA’s ac­cel­er­at­ed nod back in 2016 with con­fir­ma­to­ry tri­als on­go­ing.

Mark Pruzan­s­ki

In­ter­cept had pinned its fu­ture suc­cess on tak­ing obeti­cholic acid in­to obe­si­ty-re­lat­ed liv­er dis­ease NASH, a field ripe with fail­ures. In June, de­spite win­ning Phase III da­ta, the FDA hand­ed In­ter­cept a com­plete re­sponse let­ter for its NASH ap­pli­ca­tion, shut­ting down hopes, at least for now, at a mas­sive un­tapped mar­ket.

At is­sue was the FDA’s un­cer­tain­ty whether the sur­ro­gate end­point from their Phase III test — re­duc­tion in liv­er fi­bro­sis — would ac­tu­al­ly trans­late in­to ben­e­fit for pa­tients. The FDA in­vit­ed them to re-sub­mit with longer term da­ta from the Phase III tri­al, and In­ter­cept says it still plans to do that. At the time, then-CEO Mark Pruzan­s­ki blast­ed the call, say­ing:

At no point dur­ing the re­view did the FDA com­mu­ni­cate that OCA was not ap­prov­able on an ac­cel­er­at­ed ba­sis, and we strong­ly be­lieve that the to­tal­i­ty of da­ta sub­mit­ted to date both meet the re­quire­ments of the Agency’s own guid­ance and clear­ly sup­port the pos­i­tive ben­e­fit-risk pro­file of OCA.

The newest safe­ty sig­nals could cer­tain­ly flip that ben­e­fit-risk pro­file, adding more un­cer­tain­ty to the drug’s shot at NASH with an ac­cel­er­at­ed ap­proval off the ta­ble.

De­spite In­ter­cept’s pooh-pooh over its la­bel set­back, the new con­traindi­ca­tion comes af­ter a wave of de­par­tures at the firm fol­low­ing the agency’s CRL, most re­cent­ly capped by CFO Sandip Ka­pa­dia hit­ting the ex­it in March. In the months af­ter the FDA re­fusal, Pruzan­s­ki him­self hand­ed over the reins to Jer­ry Dur­so and the com­pa­ny’s CMO, Ja­son Cam­pagna, left to be a CMO of a much small­er up­start.

May 27, 2021 at 07:43PM
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FDA adds new 'do not use' note to Intercept's Ocaliva label after a slew of side effect reports in cirrhosis patients - Endpoints News

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