Picking a few Inclisiran comments from the report, they are still looking for an action date of Jan. 1, 2022.
Basel, October 26, 2021 - commenting on the quarter, Vas Narasimhan, CEO of Novartis, said:
“Novartis delivered strong Innovative Medicines performance, driven by the continued momentum of Cosentyx and Entresto, allowing us to raise peak sales guidance for these products. Rejuvenation of our portfolio continues, from our key brands which include Kesimpta, Leqvio, Zolgensma and the oncology portfolio. We are also commencing a strategic review of Sandoz to maximize shareholder value. We remain confident in the strength of our pipeline and launch brands to fuel the growth of our company in the mid to longer term.”
Ph3 ORION-9, -10 and -11 pooled post hoc analyses data showed that Leqvio consistently reduced LDL cholesterol in ASCVD patients with established cerebrovascular disease (55.2% reduction vs. placebo) and polyvascular disease (48.9% reduction vs. placebo)
Resubmission to the FDA for the inclisiran NDA was filed with an action date of January 1, 2022