MONDAY, Nov. 18, 2019 (HealthDay News) -- The U.S. Food and Drug Administration has approved Adakveo (crizanlizumab-tmca), the first treatment to reduce the frequency of vaso-occlusive crisis in patients with sickle cell disease, the agency announced last week.
Adakveo is indicated for treatment of patients age 16 years and older. Dosage is 5 mg/kg administered by intravenous infusion for 30 minutes to be repeated two weeks after and then every four weeks thereafter.
Approval was based on data from a randomized clinical trial of 198 patients with sickle cell disease and a history of vaso-occlusive crisis. Patients who received Adakveo had a median annual rate of 1.63 health care visits for vaso-occlusive crisis compared with a median rate of 2.98 visits per year for those who received placebo. Thirty-six percent of patients who received Adakveo did not have a vaso-occlusive crisis during the study period. Adakveo treatment delayed time to first vaso-occlusive crisis from 1.4 to 4.1 months after treatment initiation.
The most commonly reported side effects with Adakveo included back pain, nausea, fever, and arthralgia. Clinicians should monitor patients for infusion-related reactions; in the case of severe reactions, Adakveo should be discontinued. Patients should also be monitored for interference with automated platelet counts or platelet clumping when taking Adakveo.
Approval was granted to Novartis.