Press Release: Novartis Fabhalta(R) shows -2-
Werte in diesem Artikel
actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.
About Novartis
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.
Reimagine medicine with us: Visit us at https://www.novartis.com/ https://www.novartis.com and connect with us on https://www.linkedin.com/company/novartis/ LinkedIn, https://www.facebook.com/novartis/ Facebook, https://twitter.com/Novartis X/Twitter and https://instagram.com/novartis?igshid=MzRlODBiNWFlZA== Instagram.
References
1. Novartis. Data on file.
2. Clinicaltrials.gov. NCT05630001. Single Arm, Open Label Trial With
Iptacopan Treatment for 24 Weeks, in Patients on Stable Regimen of
Anti-C5 Who Switch to Iptacopan. (APPULSE). Available from:
https://clinicaltrials.gov/study/NCT05630001 Accessed May, 2025.
3. Montan I, Löwe B, Cella D, Mehnert A, Hinz A. General Population
Norms for the Functional Assessment of Chronic Illness Therapy
(FACIT)-Fatigue Scale. Value Health. 2018;21(11):1313-1321.
doi:10.1016/j.jval.2018.03.013
4. Cella D, Lai JS, Chang CH, Peterman A, Slavin M. Fatigue in cancer
patients compared with fatigue in the general United States population.
Cancer. 2002;94(2):528-538. doi:10.1002/cncr.10245
5. Peffault de Latour R, Röth A, Kulasekararaj AG, et al. Oral
Iptacopan Monotherapy in Paroxysmal Nocturnal Hemoglobinuria. N Engl J
Med. 2024;390(11):994-1008. doi:10.1056/NEJMoa2308695
6. Cançado RD, Araújo ADS, Sandes AF, et al. Consensus statement
for diagnosis and treatment of paroxysmal nocturnal haemoglobinuria.
Hematol Transfus Cell Ther. 2021;43(3):341-348.
7. Dingli D, Matos JE, Lehrhaupt K, et al. The burden of illness in patients
with paroxysmal nocturnal hemoglobinuria receiving treatment with the
C5-inhibitors eculizumab or ravulizumab: results from a US patient
survey. Ann Hematol. 2022;101(2):251-263.
8. Hill A, DeZern AE, Kinoshita T, Brodsky RA. Paroxysmal nocturnal
haemoglobinuria. Nat Rev Dis Primers. 2017;3:17028.
9. Röth A, Maciejewski J, Nishimura JI, Jain D, Weitz JI. Screening and
diagnostic clinical algorithm for paroxysmal nocturnal hemoglobinuria:
Expert consensus. Eur J Haematol. 2018;101(1):3-11.
10. Levy AR, Dysart L, Patel Y, et al. Comparison of Lost Productivity Due to
Eculizumab and Ravulizumab Treatments for Paroxysmal Nocturnal
Hemoglobinuria in France, Germany, Italy, Russia, Spain, the United
Kingdom, and the United States. Blood. 2019;134(Supplement_1):4803.
11. McKinley CE, Richards SJ, Munir T, et al. Extravascular Hemolysis Due to
C3-Loading in Patients with PNH Treated with Eculizumab: Defining the
Clinical Syndrome. Blood. 2017;130(Supplement 1):3471.
12. Risitano AM, Marotta S, Ricci P, et al. Anti-complement Treatment for
Paroxysmal Nocturnal Hemoglobinuria: Time for Proximal Complement
Inhibition? A Position Paper From the SAAWP of the EBMT. Front Immunol.
2019;10:1157.
13. Shammo J, Kim J, Georget M, et al. P796: Hospitalization in patients with
paroxysmal nocturnal hemoglobinuria: a retrospective analysis of
observational study data from the United States. Hemasphere.
2023;7(Suppl):e22585a2.
14. Debureaux PE, Kulasekararaj AG, Cacace F, et al. Categorizing
hematological response to eculizumab in paroxysmal nocturnal
hemoglobinuria: a multicenter real-life study. Bone Marrow Transplant.
2021;56(10):2600-2602.
15. Schrezenmeier H, Kulasekararaj A, Mitchell L, et al. One-year efficacy
and safety of ravulizumab in adults with paroxysmal nocturnal
hemoglobinuria naïve to complement inhibitor therapy: open-label
extension of a randomized study. Ther Adv Hematol.
2020;11:2040620720966137.
16. Young NS, Meyers G, Schrezenmeier H, Hillmen P, Hill A. The management of
paroxysmal nocturnal hemoglobinuria: recent advances in diagnosis and
treatment and new hope for patients. Semin Hematol. 2009;46(1 Suppl
1):S1-S16.
17. Risitano AM, Araten DJ, Kuter D, et al. Pb2063: APPULSE-PNH: A phase IIIB
trial to evaluate the efficacy and safety of switching to iptacopan in
patients with paroxysmal nocturnal hemoglobinuria (PNH) on anti-c5
therapy with hemoglobin >10g/dl. Hemasphere. 2023;7(Suppl):e08587b7.
18. Clinicaltrials.gov. NCT04558918. Study of Efficacy and Safety of Twice
Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite
Anti-C5 Antibody Treatment (APPLY-PNH). Available from:
https://clinicaltrials.gov/study/NCT04558918 Accessed May, 2025.
19. Risitano AM, Han B, Ueda Y, et al. Oral Complement Factor B Inhibitor
Iptacopan Monotherapy Improves Hemoglobin to Normal/Near-Normal Levels in
Paroxysmal Nocturnal Hemoglobinuria Patients Naïve to Complement
Inhibitors: Phase III APPOINT-PNH Trial. Presented at: 49th Annual
Meeting of the European Society for Blood and Marrow Transplantation
(EBMT); April 23-36, 2023; Paris, France.
20. Clinicaltrials.gov. NCT04820530. Study of Efficacy and Safety of Twice
Daily Oral Iptacopan (LNP023) in Adult PNH Patients Who Are Naive to
Complement Inhibitor Therapy (APPOINT-PNH). Available from:
https://clinicaltrials.gov/study/NCT04820530 Accessed May, 2025.
21. Kavanagh D, Bomback A, Vivarelli M, et al. Efficacy and Safety of
Iptacopan in Patients with C3 Glomerulopathy: Results from the Phase 3
APPEAR-C3G Trial. Presented at European Renal Association (ERA) Congress;
May 25, 2024; Stockholm, Sweden.
22. Smith RJ, Kavanagh D, Vivarelli M, et al. Efficacy and safety of
iptacopan in patients with C3 glomerulopathy: 12-Month results from the
Phase 3 APPEAR-C3G study. Presented at American Society of Nephrology
(ASN) Kidney Week 2024; October 23-27, 2024; San Diego, CA.
23. Novartis. Press release. Novartis receives FDA approval for Fabhalta(R)
(iptacopan), offering superior hemoglobin improvement in the absence of
transfusions as the first oral monotherapy for adults with PNH. Available
from:
https://www.novartis.com/news/media-releases/novartis-receives-fda-approval-fabhalta-iptacopan-offering-superior-hemoglobin-improvement-absence-transfusions-first-oral-monotherapy-adults-pnh
Accessed May, 2025.
24. Novartis. Press release. Novartis receives FDA accelerated approval for
Fabhalta(R) (iptacopan), the first and only complement inhibitor for the
reduction of proteinuria in primary IgA nephropathy (IgAN). Available
from:
https://www.novartis.com/news/media-releases/novartis-receives-fda-accelerated-approval-fabhalta-iptacopan-first-and-only-complement-inhibitor-reduction-proteinuria-primary-iga-nephropathy-igan
Accessed May, 2025.
25. Novartis. Press release. Novartis receives third FDA approval for oral
Fabhalta(R) (iptacopan) -- the first and only treatment approved in C3
glomerulopathy (C3G). Available from:
https://www.novartis.com/news/media-releases/novartis-receives-third-fda-approval-oral-fabhalta-iptacopan-first-and-only-treatment-approved-c3-glomerulopathy-c3g
Accessed May, 2025.
26. Novartis. Press release. Novartis oral Fabhalta(R) (iptacopan) receives
positive CHMP opinion for the treatment of adults living with C3
glomerulopathy (C3G). Available from:
https://www.novartis.com/news/media-releases/novartis-oral-fabhalta-iptacopan-receives-positive-chmp-opinion-treatment-adults-living-c3-glomerulopathy-c3g
Accessed May, 2025.
27. Fabhalta(R). US FDA Prescribing information. East Hanover, NJ:Novartis
Pharmaceuticals Corp; 2024. Available
from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218276s00
1lbl.pdf Accessed May, 2025.
28. Fabhalta(R). EMA Summary of Product Characteristics. Novartis Europharm
Limited; 2024. Available from:
https://www.ema.europa.eu/en/documents/product-information/fabhalta-epar-product-information_en.pdf
Accessed May, 2025.
29. Martín B, Smith RJH. C3 Glomerulopathy. In: Adam MP, Feldman J,
Mirzaa GM, et al, eds. GeneReviews(R) [Internet]. Seattle, WA: University
of Washington, Seattle; 1993-2025. Updated April 5, 2018. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK1425/ Accessed May, 2025.
30. Schena FP, Esposito P, Rossini M. A Narrative Review on C3
Glomerulopathy: A Rare Renal Disease. Int J Mol Sci. 2020;21(2):525.
31. Caravaca-Fontán F, Lucientes L, Cavero T, Praga M. Update on C3
Glomerulopathy: A Complement-Mediated Disease. Nephron.
2020;144(6):272-280.
32. Clinicaltrials.gov. NCT04578834. Study of Efficacy and Safety of LNP023
in Primary IgA Nephropathy Patients (APPLAUSE-IgAN). Available from:
https://clinicaltrials.gov/study/NCT04578834 Accessed May, 2025.
33. Clinicaltrials.gov. NCT04889430. Efficacy and Safety of Iptacopan
(LNP023) in Adult Patients With Atypical Hemolytic Uremic Syndrome Naive
to Complement Inhibitor Therapy (APPELHUS). Available from:
https://clinicaltrials.gov/study/NCT04889430 Accessed May, 2025.
34. Clinicaltrials.gov. NCT05755386. Study of Efficacy and Safety of
(MORE TO FOLLOW) Dow Jones Newswires
June 12, 2025 02:00 ET (06:00 GMT)
Ausgewählte Hebelprodukte auf Novartis
Mit Knock-outs können spekulative Anleger überproportional an Kursbewegungen partizipieren. Wählen Sie einfach den gewünschten Hebel und wir zeigen Ihnen passende Open-End Produkte auf Novartis
Der Hebel muss zwischen 2 und 20 liegen
Name | Hebel | KO | Emittent |
---|
Name | Hebel | KO | Emittent |
---|
Nachrichten zu Novartis AG
Analysen zu Novartis AG
Datum | Rating | Analyst | |
---|---|---|---|
12.06.2025 | Novartis Hold | Joh. Berenberg, Gossler & Co. KG (Berenberg Bank) | |
09.06.2025 | Novartis Buy | Deutsche Bank AG | |
16.05.2025 | Novartis Hold | Joh. Berenberg, Gossler & Co. KG (Berenberg Bank) | |
02.05.2025 | Novartis Hold | Joh. Berenberg, Gossler & Co. KG (Berenberg Bank) | |
01.05.2025 | Novartis Neutral | Goldman Sachs Group Inc. |
Datum | Rating | Analyst | |
---|---|---|---|
09.06.2025 | Novartis Buy | Deutsche Bank AG | |
30.04.2025 | Novartis Buy | Deutsche Bank AG | |
30.04.2025 | Novartis Kaufen | DZ BANK | |
29.04.2025 | Novartis Outperform | Bernstein Research | |
07.04.2025 | Novartis Buy | Deutsche Bank AG |
Datum | Rating | Analyst | |
---|---|---|---|
12.06.2025 | Novartis Hold | Joh. Berenberg, Gossler & Co. KG (Berenberg Bank) | |
16.05.2025 | Novartis Hold | Joh. Berenberg, Gossler & Co. KG (Berenberg Bank) | |
02.05.2025 | Novartis Hold | Joh. Berenberg, Gossler & Co. KG (Berenberg Bank) | |
01.05.2025 | Novartis Neutral | Goldman Sachs Group Inc. | |
29.04.2025 | Novartis Hold | Jefferies & Company Inc. |
Datum | Rating | Analyst | |
---|---|---|---|
21.11.2024 | Novartis Underweight | Barclays Capital | |
24.06.2024 | Novartis Underweight | Barclays Capital | |
23.04.2024 | Novartis Underweight | Barclays Capital | |
28.03.2024 | Novartis Underweight | Barclays Capital | |
06.02.2024 | Novartis Underweight | Barclays Capital |
Um die Übersicht zu verbessern, haben Sie die Möglichkeit, die Analysen für Novartis AG nach folgenden Kriterien zu filtern.
Alle: Alle Empfehlungen