FDA approves AbbVie’s 24-hour Parkinson’s infusion therapy after two CRLs

The FDA has fi­nal­ly ap­proved Ab­b­Vie’s in­fused Parkin­son’s drug for pa­tients who don’t re­spond to wide­ly used oral ther­a­pies.

The drug, for­mer­ly known as AB­BV-951, will be sold un­der the brand name Vyalev. It is a 24-hour con­tin­u­ous in­fu­sion of pro­drugs of lev­odopa and car­bidopa, two wide­ly-used drugs in Parkin­son’s treat­ment. It can pro­vide an­oth­er op­tion for ad­vanced Parkin­son’s pa­tients be­fore more se­ri­ous in­ter­ven­tions.

Vyalev’s an­nu­al whole­sale ac­qui­si­tion cost is ap­prox­i­mate­ly $119,000 per pa­tient, an Ab­b­Vie spokesper­son told End­points News.

The ap­proval comes three years af­ter Vyalev read out pos­i­tive Phase 3 da­ta, show­ing it suc­ceed­ed on the pri­ma­ry end­point of change in base­line “on” time with­out in­vol­un­tary move­ments af­ter 12 weeks. The av­er­age in­crease was 2.72 hours of “on” time for pa­tients tak­ing the drug, com­pared with 0.97 hours for those on stan­dard of care, good for a p-val­ue of p=0.0083.

Be­fore Thurs­day’s ap­proval, the pro­gram suf­fered two re­jec­tions: one in March 2023 af­ter the FDA asked for more in­for­ma­tion about the ther­a­py’s in­fu­sion pump de­vice, and an­oth­er in June af­ter the FDA cit­ed is­sues at a third-par­ty man­u­fac­tur­ing site.

The Ab­b­Vie spokesper­son de­clined to com­ment on what the man­u­fac­tur­ing is­sues were or what the com­pa­ny had done to re­solve them.

Vyalev is ad­min­is­tered through an in­fu­sion pump de­vice that is de­signed to be portable and wear­able. Ide­al­ly, ad­vanced Parkin­son’s pa­tients would take the drug be­fore re­ceiv­ing deep brain stim­u­la­tion surgery, tri­al in­ves­ti­ga­tor Robert Hauser told End­points ahead of the June re­jec­tion. The ef­fec­tive­ness of lev­odopa and car­bidopa wanes over time, leav­ing such in­di­vid­u­als with few al­ter­na­tives.

In ad­di­tion to Vyalev, Ab­b­Vie could bring an­oth­er Parkin­son’s drug to mar­ket in the near fu­ture. Tava­padon, a pro­gram Ab­b­Vie ac­quired in its near­ly $9 bil­lion buy­out of Cerev­el Ther­a­peu­tics, has suc­ceed­ed in two Phase 3 tri­als this year look­ing at monother­a­py and ad­junc­tive set­tings. A third study is ex­pect­ed to read out by the end of the year.