Here are the 52 new drugs ap­proved by the FDA in 2019. Who won? Who lost? And who just sur­vived to 2020?

The R&D crown for great­est suc­cess at the FDA in 2019 is go­ing to have to be shared.

Glanc­ing over the 52 new drugs OK’d in the last year — all bro­ken down be­low in­to in­di­vid­ual takes — and your eye is im­me­di­ate­ly drawn to No­var­tis in the win col­umn. Their 6 new drug ap­provals in­cludes 4 prospec­tive block­busters in wide­ly di­ver­gent fields:

  • Mayzent (sipon­i­mod) for mul­ti­ple scle­ro­sis, a land­mark ther­a­py that is the first for sec­ondary pro­gres­sive cas­es.
  • Piqray (alpelis­ib) in breast can­cer.
  • Beovu (brolu­cizum­ab) for wet AMD, a new and po­ten­tial­ly dis­rup­tive ri­val to Re­gen­eron’s cru­cial cash cow.
  • And Zol­gens­ma, its gene ther­a­py for SMA, still set to roil Bio­gen’s world de­spite the fra­cas around the ma­nip­u­lat­ed da­ta in­clud­ed in the ap­pli­ca­tion (and kept hid­den un­til af­ter the ap­proval.)

In­clude an ap­proval for their “break­through” drug Adakveo (crizan­l­izum­ab) for sick­le cell dis­ease and a thumbs-up for Egat­en, an old drug they’ve giv­en away glob­al­ly, and you have an im­pres­sive run for the R&D group. Add it all up and the an­a­lysts are track­ing new­ly mar­ket­ed ther­a­pies at the gi­ant phar­ma that have the po­ten­tial to make more than $7 bil­lion a year — though we’ll be the first to con­cede that many of the most rosy sales fore­casts of­ten have to be walked back lat­er in the face of bit­ter re­al­i­ties.

How­ev­er you cut it, that’s an out­stand­ing year for one of the world’s top R&D spenders. If No­var­tis could shed the habit of trig­ger­ing reg­u­lar ethics scan­dals, they could spend a lot more time cel­e­brat­ing suc­cess­es and the wins you can buy your­self when pock­ets run deep.

So who’s go­ing to chal­lenge No­var­tis for the 2019 heavy­weight ti­tle?


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