Basilea push­es back FDA sub­mis­sion for an­tibi­ot­ic over CMO is­sues

Basilea Phar­ma­ceu­ti­ca said it’s en­coun­ter­ing a man­u­fac­tur­ing de­lay that will af­fect when the com­pa­ny is able to sub­mit its an­tibi­ot­ic cefto­bip­ro­le for FDA ap­proval.

The Swiss biotech an­nounced Tues­day that it will take an es­ti­mat­ed three to six months to en­sure that one of its third-par­ty con­tract man­u­fac­tur­ers will be ready for in­spec­tion by the FDA.

Basilea now ex­pects to sub­mit cefto­bip­ro­le, al­so known as Zevtera, to the FDA in the third quar­ter of this year, and a reg­u­la­to­ry de­ci­sion is ex­pect­ed in the sec­ond quar­ter of 2024, CEO David Veitch said in a news re­lease. The biotech plans to sub­mit the drug for three in­di­ca­tions in the US, in­clud­ing Staphy­lo­coc­cus au­reus bac­teremia, com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia, and acute bac­te­r­i­al skin and skin struc­ture in­fec­tions. In 2020, the drug was ap­proved for treat­ing com­mu­ni­ty and hos­pi­tal-ac­quired pneu­mo­nia in Chi­na and got mar­ket­ing au­tho­riza­tion in Brazil for the in­di­ca­tions last year.

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