CSL Behring has submitted a Variation Application to the European Medicines Agency (EMA) for the use of Privigen (immune globulin intravenous [human], 10% liquid for intravenous administration) in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP).
The company submitted the application based on results of the PRIMA study (Privigen Impact on Mobility and Autonomy), a single-arm study designed to evaluate the safety and efficacy of Privigen in 31 patients who have CIDP.
Patients on Privigen in the study demonstrated a statistically significant change in their INCAT score at the completion visit, meeting the primary endpoint with a clinically meaningful improvement in their disease.
Fifty per cent of the 61% of patients responded to Privigen responded within four weeks of being treated in the study.
Privigen also demonstrated improvements on secondary endpoints, including objective measures of muscle strength of the hands at the completion visit, said the company.
CSL Behring senior vice president of Global Clinical R&D Russell Basser said the data contained in this application provide clinical evidence that Privigen is a safe and efficacious option for CIDP patients in Europe who are managing this very challenging condition.
"If approved in Europe for use in treating CIDP, Privigen will represent a meaningful advance in many rare disease communities across the continent," Basser said.
CIDP is a neurological disorder of the peripheral nerves characterized by symmetrical weakness in the arms and legs that progressively worsens for longer than two months.