Novartis highlights confidence in growing sales with margin expansion, fueled by in-market brands and a rich pipeline, at Annual Meet the Management investor event - Seite 2
The company is advancing sustained lifecycle management for many assets with five key programs highlighted at the meeting:
- Entresto (sacubitril/valsartan) is under review for the treatment of heart failure with preserved ejection fraction (HFpEF) with a US regulatory decision expected in the first quarter of 2021. Phase III results are expected in the first half of next year from the PARADISE MI trial studying Entresto in patients with acute myocardial infarction (AMI).
- Cosentyx (secukinumab) continues to show strength in dermatology and findings from a Phase III trial in hidradenitis suppurativa (HS) are expected in the second half of 2021.
- Kisqali (ribociclib) continues to grow in-market with overall survival (OS) data in aBC from the MONALEESA-2 trial anticipated in the second half of 2021.
- Alpelisib (BYL719) is on track for a US submission in PIK3CA-Related Overgrowth Spectrum (PROS) in 2021.
- Beovu (brolucizumab) is progressing in Phase III development for diabetic macular edema (DME) with a potential submission planned in 2021.
From the many assets in the Pharmaceuticals business unit, Novartis is also highlighting multiple mid- to late-stage assets with key milestones expected in 2021 and 2022:
- Iptacopan (LNP023), a potential first-in-class oral factor B inhibitor in development for several rare renal diseases and a hematological disorder, is expected to begin Phase III development for IgA Nephropathy (IgAN) in the first half of 2021. The European Medicines Agency (EMA) has granted orphan drug designation to iptacopan for the treatment of IgAN and PRIME designation in C3G.
- Iscalimab (CFZ533) is an anti-CD40 antibody in development across multiple indications including Sjögren’s syndrome, kidney and liver transplantation; with first results expected in 2022.
- The Phase III clinical trials for the next-generation anti-IgE/FcεRI antibody ligelizumab (QGE031) in chronic spontaneous urticaria (CSU) are fully enrolled, with results expected in the second half of 2021 and regulatory submission in 2022.
- In December 2019, Novartis initiated a Phase III outcomes study for pelacarsen (TQJ230), a potential first-in-class antisense oligonucleotide for secondary prevention of cardiovascular events in patients with elevated levels of lipoprotein (a). Results are expected in 2024.
Inclisiran (Leqvio) has received positive CHMP opinion for the treatment of adults with hypercholesterolemia
or mixed dyslipidemia, marking an important milestone towards it becoming potentially available in the EU. Currently under regulatory review with the FDA with an action date of December 2020.