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.