Am­i­cus eyes Pompe ap­proval; Atea ends Dengue work; 2sev­en­ty, Tra­vere line up of­fer­ings

Am­i­cus Ther­a­peu­tics be­gan March with word that the FDA has sched­uled a pre-ap­proval in­spec­tion of its po­ten­tial treat­ment for Pompe dis­ease. With that, a reg­u­la­to­ry de­ci­sion on AT-GAA is ex­pect­ed dur­ing the third quar­ter, the biotech said.

Am­i­cus said last Oc­to­ber the FDA wasn’t able to do the re­quired in­spec­tion of its man­u­fac­tur­ing part­ner, WuXi Bi­o­log­ics in Chi­na, dur­ing the re­view time­frame be­cause of “re­stric­tions on trav­el re­lat­ed” to the pan­dem­ic. AT-GAA con­sists of bi­o­log­ic cipaglu­cosi­dase al­fa and miglu­s­tat, a sta­bi­liz­er of the bi­o­log­ic. The ap­proval re­quest in­cludes both a BLA and NDA.

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