New Novartis medicine Adakveo (crizanlizumab) approved by FDA to reduce frequency of pain crises in individuals living with sickle cell disease
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
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- Sickle cell pain crises are unpredictable, severe events associated with life-threatening complications1
- Adakveo reduced the annual rate of sickle cell pain crises by 45% compared to placebo (1.63 vs 2.98) and the annual rate of days hospitalized (4 vs 6.87) in a 52-week study2
- Approximately 100,000 people in the United States, most of whom are of African descent, have sickle cell disease3
- Approval comes approximately two months ahead of FDA?s priority review action date, allowing Adakveo to be available to patients more quickly
- A decrease in the median annual rate of days hospitalized to 4 vs 6.87 days when compared with placebo (a 42% reduction)
- Thirty-six percent of patients treated with Adakveo did not experience a VOC, compared to 17% of placebo-treated patients
- The median time to first VOC was 4.1 for Adakveo vs 1.4 months for placebo
- Steinberg M. Management of sickle cell disease.?N Engl J Med. 1999;340(13):1021-1030.
- Ataga KI, Kutlar A, Kanter J et al. Crizanlizumab for the prevention of pain crises in sickle cell disease.?N Engl J Med.?2017;376(5):429-439.
- American Society of Hematology. State of sickle cell disease 2016 report.?http://www.scdcoalition.org/pdfs/ASH%20State%20of%20Sickle%20Cell%20Dise.... Accessed October 24, 2019.
- Adakveo (crizanlizumab) prescribing information. East Hanover, New Jersey, USA. Novartis Pharmaceuticals Corporation; November 2019.
- Rees DC, Williams TN, Gladwin MT. Sickle-cell disease.?Lancet. 2010;376(9757):2018-2031.
- Lawrence MB, Springer TA. Leukocytes roll on a selectin at physiologic flow rates: distinction from and prerequisite for adhesion through integrins.?Cell. 1991;65(5):859-873.
- Gutsaeva D, Parkerson J, Yerigenahally S, et al. Inhibition of cell adhesion by anti?P-selectin aptamer: a new potential therapeutic agent for sickle cell disease.?Blood. 2011;117(2):727-735.
- Sparkenbaugh E, Pawlinski R. Interplay between coagulation and vascular inflammation in sickle cell disease.?Br?J Haematol. 2013;162(1):1-22.
- Ballas SK, Gupta K, Adams-Graves P. Sickle cell pain: a critical reappraisal.?Blood. 2012;120(18):3647-3656.
- Yusuf HR, Atrash HK, Grosse SD, Parker CS, Grant AM. Emergency department visits made by patients with sickle cell disease: a descriptive study, 1999-2007.Am J Prev Med. 2010;38(Suppl):S536-S541.
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Novartis Global External Communications E-mail:?media.relations@novartis.comAntonio Ligi Novartis Global Media Relations +41 61 324 1374 (direct) +41 79 723 3681 (mobile) antonio.ligi@novartis.comEric Althoff Novartis US External Communications + 1 646 438 4335 eric.althoff@novartis.com | Michael Billings Novartis Hematology Communications +1 862 778 8656 (direct) +1 201 400 1854 (mobile) Michael.billings@novartis.com |
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