Sickle Cell Disease News is strictly a news and information website about the disease. Tagged Adakveo, crizanlizumab, FDA approval, Novartis, SUSTAIN study, vaso-occlusive crises, VOCs. The SUSTAIN study, conducted primarily in the United States, evaluated clinically meaningful end points across a diverse patient population aged 16 years and over1,2. Now you can find the tools you need to help manage your patients, all in one place! Maintenance: 5 mg/kg every 4 weeks beginning at week 6 . For information on site of service for crizanlizumab (Adakveo), see Utilization Management Policy on Site of Care for Specialty Drug Infusions. The most common adverse reactions (≥10%) were nausea,arthralgia, back pain,andpyrexia. margin-left: 0px !important; If ADAKVEO is administered within 2 weeks after the missed dose, continue dosing according to the patient's original schedule. We are sorry that this post was not useful for you! The FDA's decision to approve Adakveo 5 mg/kg is based on results of the 52-week, randomized, placebo-controlled SUSTAIN trial, which showed that Adakveo significantly lowered the median annual rate of VOCs to 1.63 vs 2.98 compared to placebo (P=.010), which is equivalent to a 45% reduction. Adakveo, a man-made antibody, works to block the activity of P-selectin, an adhesion protein that makes sickled blood cells more sticky and more likely to clog blood vessels, causing inflammation and pain crises. } Results are based on a noncomparative post hoc analysis and are observational in nature; as such, they are not powered to show statistical significance. Data on file. “Adakveo is the first targeted therapy approved for sickle cell disease, specifically inhibiting selectin, a substance that contributes to cells sticking together and leads to vaso-occlusive crisis,” Richard Pazdur, MD, director of the Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the Center for Drug Evaluation and Research, said in an agency press release. The study’s main goal was to evaluate the impact of treatment on the frequency of annual VOCs requiring a visit to a medical facility and treatment with either opioids or nonsteroidal anti-inflammatory drugs (NSAIDs) to control pain. Run blood samples within 4 hours of blood collection or collect blood samples in tubes containing citrate. Monitor patients for signs and symptoms of infusion-related reactions, which may include fever, chills, nausea, vomiting, fatigue, dizziness, pruritus, urticaria, sweating, or shortness of breath or wheezing. line-height: 1.2; } Novartis Pharmaceuticals Corp; 2016. You’ll have access to the site in a moment, or click continue to close this message and advance directly to the site. The SUSTAIN Study Video Summary of Original Article Feb 02, 2017 Crizanlizumab for the Prevention of Pain Crises in Sickle Cell Disease K. I. Ataga and Others Per-protocol population is a subset of the ITT patient population who received at least 12 of the 14 planned doses of ADAKVEO (n=40) or placebo (n=41), completed a visit at least 14 days after final dose of study drug, and had no major protocol violations. Basel, October 30, 2020 — Novartis today announced that the European Commission (EC) has approved Adakveo (crizanlizumab) for the prevention of recurrent vaso-occlusive crises (VOCs), or pain crises, in patients with sickle cell disease aged 16 years and older. Copyright © 2013-2021 All rights reserved. We’re moving on! CHMP granted positive opinion in July this year, based on results from the 52-week, randomised, placebo-controlled SUSTAIN trial. It is not known if Adakveo is safe and effective in children under 16 years of age. ADAKVEO® is indicated to reduce the frequency of vasoocclusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease. Adakveo ® (crizanlizumab-tmca) is used in people 16 years of age and older, who have sickle cell disease, to help reduce how often certain episodes of pain (crises) happen. The CHMP opinion was based on results of the 52-week, randomized, placebo-controlled SUSTAIN trial, which showed that Adakveo significantly lowered the median annual rate of VOCs to 1.63 vs 2.98 compared to placebo (P=.010), equivalent to a 45% reduction. .uso-brand-details h3.brandColor { 1 Adakveo can be given as an add-on therapy to hydroxyurea/hydroxycarbamide (HU/HC) or as monotherapy in patients for whom … “We are pleased to help reimagine medicine together with the sickle cell community and offer new hope for fewer VOCs.”. Member is not concurrently enrolled in a clinical trial to receive an experimental therapy for SCD e. Dose does not exceed the following: i. In the 52-week SUSTAIN study, ADAKVEO was proven to reduce the frequency of VOCs 1 Significant 45% (1.63 vs 2.98) reduction in the median annual rate of VOCs vs placebo 1,2 * Reduction in the frequency of VOC s was observed regardless of VOC baseline … By inhibiting the activity of P-selectin, Adakveo helps to stop red blood cells from adhering to blood vessel walls, allowing for better blood flow and working to prevent inflammation and pain. If you do not wish to leave this site, click Cancel. font-size: 21px !important; Or click OK to continue. font-size: 11px !important; 1 Adakveo can be given as an add-on therapy to hydroxyurea/hydroxycarbamide (HU/HC) or as monotherapy in patients for whom HU/HC is …