Novartis (NVS)

[DewDiligence]

FDA approves NVS’ Leqvio—(inclisiran)—for lowering LDL-C:

https://www.prnewswire.com/news-releases/fda-approves-novartis-leqvio-inclisiran-first-in-class-sirna-to-lower-cholesterol-and-keep-it-low-with-two-doses-a-year-301450125.html

NVS initially received a CRL from the FDA in late 2020 due to the FDA’s inability to conduct an inspection of the Leqvio’s manufacturing site in Italy (#msg-160327185).

Leqvio is a siRNA dosed semiannually (except for the 3-month interval between the first two doses). NVS picked up this drug when it acquired MDCO in Nov 2019 (#msg-152458295).

ALNY, which will get a 10-20% royalty on global sales, discovered Inclisiran and out-licensed it to MDCO in 2013 (#msg-84151150); with the benefit of hindsight we can say that MDCO clearly got the better of ALNY in this deal.

Leqvio was approved in the EI in late 2020 (https://www.novartis.com/news/media-releases/novartis-receives-eu-approval-leqvio-inclisiran-first-class-sirna-lower-cholesterol-two-doses-year ).