MedImmune, the global biologics unit of AstraZeneca, has submitted a Marketing Authorisation Application (MAA) for its nasal spray live attenuated influenza vaccine (LAIV), which is now being reviewed by the European Medicines Agency (EMEA). The proposed indication in the MAA is for prevention of seasonal influenza.

The MAA submission for LAIV is based on data from 73 global clinical and US post-marketing studies of more than 141,000 subjects ranging in age from seven weeks to 97 years and conducted in 38 countries. Study objectives have included clinical safety and tolerability, clinical efficacy and effectiveness, and immunogenicity.

"Influenza creates a heavy medical and economic burden on Europe and throughout the world, and we are hopeful that the future availability and product characteristics of this novel nasal spray influenza vaccine will contribute to an increase in vaccination rates and reduce the spread of influenza around the world," said Alex Zukiwski, senior vice president, clinical affairs and chief medical officer. "MedImmune is pleased to submit this application for approval of our nasal spray influenza vaccine in Europe."

MedImmune is a leading innovation-focused biotechnology company whose mission is to provide better medicines to patients, new medical options for physicians and rewarding careers to employees.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services.