This designation brings significant offers benefits to Biovest in its development and marketing of BiovaxID in the European Union.
This acceptance follows the previously announced recommendation by the European Medicines Agency that BiovaxID be granted designation as a treatment for a rare disease.
The agency concluded that the condition was chronically debilitating and life threatening providing justification that BiovaxID may be of significant benefit to those affected by the condition.
Patients with this form of lymphoma often face relapses and increasing resistance to treatments.
In the EU, products targeted to treat disorders that affect fewer than 5 in 10,000 people are eligible for designation as a drug to treat a rare disease. Such status provides significant advantages and assistance to Biovest toward final approval to market BiovaxID in the EU.
“This acceptance will provide Biovest with access to valuable resources and input from the Agency while we complete our phase III clinical study and prepare to file our marketing authorization application in the EU,” commented Dr Steve Arikan, Biovest CEO.