2021's NDA list in­cludes some ex­tra­or­di­nary ac­com­plish­ments in year #2 of the pan­dem­ic

All the big R&D trends are on dis­play in this new list of drug ap­provals for 2021. Plus one.

Add up every­thing OK’d from CDER and CBER, and you have 60 new drug ap­provals for last year, top­ping the 59 in 2020. That’s a close sec­ond to the 64 OKs that came out of the FDA in 2018. The dark days of the ear­ly 2000s are a dis­tant mem­o­ry now, with a host of hun­gry up­starts promis­ing to make their own en­tries one day as Big Phar­mas dou­ble down on in­no­va­tion.

There’s the new list of small biotechs that nailed down their first drug ap­provals, ex­press­ing noth­ing but ea­ger­ness to get out there and start mar­ket­ing — some­thing they all have much to learn about. Not all of these drugs are tip­ping the scales on the com­mer­cial side, but that doesn’t mean they aren’t im­por­tant to the small or­phan pop­u­la­tions that set this trend in mo­tion more than a decade ago.

In the mean­time the list of small­er play­ers mak­ing the leap now in­clude biotechs like Apel­lis and ADC Ther­a­peu­tics. Kad­mon hit, then sold to Sanofi. Can they per­form like the an­a­lysts have promised? Hopes and fore­casts dur­ing de­vel­op­ment are one thing, but as Bio­gen ex­ecs can tell you, sales is an un­for­giv­ing, hard-num­bers game.

There are the late ar­rivals in the win col­umn, of­ten show­ing up at the reg­u­la­to­ry fin­ish line well past sched­ule, some­times cuffed and bruised by CMC is­sues that con­tin­ue to plague the field. The FDA has shown time and again that it isn’t in a for­giv­ing mood over sus­pect man­u­fac­tur­ing prob­lems. That trend looks em­bed­ded in­to the fab­ric of the drug ap­proval process, for big and small com­pa­nies alike.

No­var­tis dealt with that, be­fore get­ting their ap­proval of Leqvio (in­clisir­an) and will now put its colos­sal shoul­der be­hind the com­mer­cial wheel in the LDL mar­ket.

The ma­jor play­ers, of course, tend­ed to dom­i­nate the list of po­ten­tial block­busters. That’s an­oth­er in­dus­try tra­di­tion. So As­traZeneca and Am­gen made no­table con­tri­bu­tions to the list, for break­through asth­ma as well as im­pres­sive can­cer drugs. Ab­b­Vie made its mark with mi­graines, which is see­ing a new wave of ther­a­pies en­ter the mar­ket.

As al­ways, sheer grit counts for much of the suc­cess. SeaGen’s suc­cess with next-gen AD­Cs is an ex­am­ple of that. As­traZeneca’s R&D staff al­most nev­er gives up, but just keeps bat­tling ahead, chang­ing tri­al de­signs, per­sist­ing. In that sense, fi­nal­ly fin­ish­ing its world head­quar­ters in Cam­bridge, UK in 2021 was a fit­ting sym­bol for the com­pa­ny’s stub­born­ness. They may not wow you with speed every time, but they get to the reg­u­la­to­ry goal posts.

But amid all the hard work and en­durance, let’s not over­look the year’s tri­umphs, topped by Al­bert Bourla’s Pfiz­er. Faced with a pan­dem­ic, Pfiz­er took its part­ner­ship with BioN­Tech to leg­end sta­tus. Its mR­NA vac­cine pro­vid­ed an in­stant burst of sales worth tens of bil­lions of dol­lars. They got there first, break­ing de­vel­op­ment and reg­u­la­to­ry bar­ri­ers, and set up a fran­chise that will help trans­form the multi­na­tion­al for the decade ahead. And let’s not for­get that they did it in a year in which they brought through Pre­vnar 20, a next-gen ap­proach that is ex­pect­ed to safe­guard one of its biggest fran­chis­es.

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