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?
Vertex.
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