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Novartis Entresto® US patent upheld by US Court of Appeals
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Basel, January 13, 2025 – Novartis is pleased with the decision by the US Court of Appeals for the Federal Circuit (CAFC) that affirms the validity of the Entresto® (sacubitril/valsartan) combination patent.
We will work to appropriately enforce the combination patent through its pediatric exclusivity period expiring in July 2025. We will also continue to defend and protect all our important intellectual property and regulatory rights relating to Entresto.
Novartis intrathecal onasemnogene abeparvovec Phase III study meets primary endpoint in children and young adults with SMA
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Ad hoc announcement pursuant to Art. 53 LR
Longer-term Novartis Kisqali® NATALEE data show durable reduction in distant recurrence in broad population of patients with early breast cancer
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- Reduction in distant recurrence consistently deepened beyond 3-year Kisqali treatment duration in patients with node-positive (N+) and high-risk node-negative (N0) disease, as well as between anatomical stages1
- Real-world 5-year distant recurrence data in high-risk patients with HR+/HER2- early breast cancer (EBC), regardless of nodal status, highlights importance of adding a CDK4/6 inhibitor to endocrine therapy for all eligible patients2
Longer-term data for Novartis Scemblix® reinforce superior efficacy with favorable safety and tolerability profile in adults with newly diagnosed CML
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- Scemblix demonstrated sustained superior major molecular response (MMR) vs. all investigator-selected TKIs (74.1% vs. 52%) and vs. imatinib alone (76.2% vs. 47.1%), meeting both ASC4FIRST 96-week key secondary endpoints1
- Scemblix showed a clinically relevant 15.1% higher MMR rate vs. second generation (2G) TKIs (72.0% vs. 56.9%)1
New Phase IIIB data shows Novartis Fabhalta® improved hemoglobin levels in adult patients with paroxysmal nocturnal hemoglobinuria who switched from anti-C5 therapy
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- In the Phase IIIB APPULSE-PNH study, oral Fabhalta® (iptacopan) improved the average hemoglobin (Hb) level versus baseline in adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who were switched from anti-C5 therapies (Hb ≥10g/dL following treatment with eculizumab or ravulizumab)1,2
Novartis bolsters Neuroscience pipeline with in-licensing of PTC518 for Huntington’s disease
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Novartis Kisqali® receives European Commission approval in a broad population of patients with HR+/HER2- early breast cancer at high risk of recurrence
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- Approval is based on Phase III NATALEE data showing Kisqali® (ribociclib) plus adjuvant endocrine therapy (ET) demonstrated clinically meaningful invasive disease-free survival (iDFS) benefit in patients with stage II or III HR+/HER2- early breast cancer (EBC), consistent across all subgroups1,2
Novartis highlights new 96-week results from Phase III Scemblix® ASC4FIRST trial at ASH and late-breaking analysis from Phase III Kisqali® NATALEE trial at SABCS
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- Longer-term 96-week results from Scemblix® ASC4FIRST Phase III study in first-line Ph+ CML-CP to be presented following recent FDA approval based on 48-week data
- Late-breaking Kisqali®* 4-year analysis on distant disease-free survival in key subgroups with HR+/HER2- early breast cancer from Phase III NATALEE trial also to be presented
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