Lev Pharmaceuticals’ Cinryze®, a prophylaxis against hereditary angioedema (HAE), was approved by the FDA after successful pivotal clinical trials managed by Atlantic Research Group. Families living with the disease are also burdened with the knowledge that the genetic condition is likely to affect their descendants. Sometimes life-threatening swelling of the airway, along with non-life-threatening swelling of the extremities are among the symptoms of the disorder.
“ARG was instrumental in helping Lev Pharmaceuticals meet timelines for our BLA submission to the FDA. Their dedicated, thorough work, management of multiple vendors, efficient monitoring teams and TrialVista® CTMS implementation were critical assets for Lev Pharmaceuticals as we prepared for this filing.”
Jason Bablak, Lev’s Vice President of Regulatory Affairs & Product Development