NOVARTIS AG Adakveo can be given as an add-on therapy to hydroxyurea/hydroxycarbamide (HU/HC) or as monotherapy in patients for whom HU/HC is inappropriate or inadequate.
Adakveo binds to P-selectin, a cell adhesion protein that plays a central role in the multicellular interactions that can lead to vaso-occlusion.2,3 Sickle cell disease is considered a rare blood condition, affecting about 50,000 people in Europe.4,5
'Data shows that nine out of ten people living with sickle cell disease experience one or more VOCs in a year, with a third of those crises leading to hospitalization, underscoring the significant unmet need among a vulnerable group of patients,' said
The approval follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in July based on results of the SUSTAIN trial, which showed that Adakveo significantly lowered the median annual rate of VOCs to 1.63 vs 2.98 compared with placebo (P=.010), equivalent to a 45% reduction. There was also a greater than two-fold increase in the proportion of patients with no VOCs who completed the study, compared to placebo. Reductions in the frequency of VOCs were observed among patients regardless of sickle cell disease genotype and/or hydroxyurea/hydroxycarbamide (HU/HC) use. In the same study, Adakveo was shown to reduce the median annual rate of days hospitalized by 42% (4.0 days for Adakveo vs. 6.87 days for placebo).6 Read more about the positive CHMP opinion and the SUSTAIN clinical trial results here.
About Adakveo
Adakveo (crizanlizumab) - previously known as SEG101 - is indicated for the prevention of recurrent VOCs in patients with sickle cell aged 16 years and older. It can be given as an add-on therapy to HU/HC or as monotherapy in patients for whom HU/HC is inappropriate or inadequate. It is the first and only targeted biologic that works by binding to P-selectin, a cell adhesion protein that plays a central role in the multicellular interactions that can lead to vaso-occlusion in sickle cell disease. By binding to P-selectin on the surface of the activated endothelium and platelets, Adakveo blocks interactions between endothelial cells, platelets, red blood cells, and leukocytes.
Adakveo is now approved in 36 countries around the world including the
Important Safety Information
Adakveo may cause serious side effects, including infusion-related reactions. Infusion-related reactions may happen within 24 hours of receiving an infusion of Adakveo. Patients should tell their doctor or nurse immediately if they experience any of the following, which may be signs and symptoms of an infusion-related reaction, such as fever, chills or shivering, nausea, vomiting, tiredness, dizziness, sweating, hives, itching, shortness of breath or wheezing, or pain. In the event of a severe reaction, crizanlizumab should be discontinued and appropriate therapy should be instituted.
The most common side effects (incidence > 10%) were arthralgia, nausea, back pain, pyrexia, and abdominal pain. Other side effects which may affect up to 1 in every 10 people are diarrhea, itching (including vulvovaginal itching), vomiting, muscle pain (myalgia), pain in the muscles or bones of the chest (musculoskeletal chest pain), sore throat (oropharyngeal pain), and redness or swelling and pain at the site of the infusion.
Adakveo may interfere with a laboratory test used to measure the number of platelets in the blood. Patients should tell their doctor or nurse that they are on treatment with Adakveo. It is recommended to run the tests as soon as possible (within 4 hours of blood collection) or use tubes containing citrate.
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About Novartis
Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world.
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