FDA grants fast track designation for smallpox vaccine

The FDA has granted Bavarian Nordic's Investigational New Drug application covering the company's third generation smallpox vaccine candidate Imvamune (Mva-Bn).

Imvamune is the first and only smallpox vaccine candidate to receive this designation.

Bavarian Nordic is currently conducting an extensive clinical development programme with Imvamune. Ongoing studies are designed to evaluate the immune response of the vaccine in comparison with Dryvax as well to evaluate the vaccine in special populations for which Dryvax is contraindicated.

The fast track designation follows other key suc-cesses including the recent signing of an agreement with GlaxoSmithKline for the production and marketing of Imvamune and the grant of a patent covering the company's MVA-BN virus and associated technology. 'We are pleased with the fast track designation for Imvamune, which recognises the importance of developing a safer smallpox vaccine,' said Peter Wulff, president and ceo of Bavarian Nordic.

Bavarian Nordic's proprietary core technology MVA-BN is one of the world's safest, multivalent vaccine vectors and is suitable for use against various infectious diseases such as smallpox, HIV/AIDS, Japanese Encephalitis and Dengue Fever. Several MVA-BN-based HIV and smallpox vaccines are in clinical Phase I and Phase II trials.

Fast Track designation

The fast track designation gives priority review status to a license application and allows filing portions of license applications ahead of others. It facilitates frequent and ongoing communication with the FDA and is intended to facilitate development and expedite the review of new therapies that are intended to treat serious or life-threatening conditions.

Dryvax - Smallpox vaccine

Dryvax is a live-virus preparation of vaccinia virus prepared from calf lymph. The calf lymph is purified, concentrated, and dried by lyophilisation.