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 considition 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's work on Cinryze® was an essential part of its confirmation by the FDA. “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,” said Jason Bablak, Lev’s Vice President of Regulatory Affairs & Product Development.
Our experience enrolling patients on challenging protocols, under very strict and high-pressure enrollment timelines (especially for conditions with low patient populations, e.g. HAE) is one of our greatest strengths. Atlantic Research Group has conducted trials associated with the following immunological/allergy-related indications: