In the EU, products targeted to treat disorders that affect fewer than five in 10,000 people are eligible for orphan designation. Orphan status will provide significant advantages and assistance to Biovest in getting final approval to market BiovaxID in the EU. These benefits include 10 years of market exclusivity in the EU once the product is approved and reduced fees for European Medicines Agency (EMEA) filings.
The committee’s positive opinion regarding BiovaxID in follicular lymphoma has now been forwarded to the EU commission for final approval and publication in the community register.
“This positive opinion follows our recent very productive meeting with EMEA representatives whereby we are seeking their guidance and advice regarding our plans to obtain approval for BiovaxID in the EU,” Dr Steve Arikian, Biovest CEO and chairman, commented. “The granting of orphan medicinal product designation in the EU will provide Biovest with access to invaluable resources and input from the agency when we prepare to file an application for marketing.”