NIJMEGEN, The Netherlands, January 6 /PRNewswire/ --
MedImmune, the global biologics unit of AstraZeneca, announced today that it 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 U.S. post-marketing studies of more than 141,000 subjects ranging in age from 7 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, M.D., executive 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.
Each dose of LAIV is formulated to contain three live attenuated influenza virus strains, which are weakened as to not cause illness: Two Type A influenza strains (A/H1N1 and A/H3N2) and one Type B strain. The vaccine strains are selected annually by the World Health Organization (WHO) based on anticipated circulating influenza strains for the upcoming season. The vaccine is sprayed into the nose, rather than by injection as with other licensed influenza vaccines, where it induces protective immunity.
In the U.S., LAIV is marketed under the trade name FluMist(R) (Influenza Virus Vaccine Live, Intranasal). It was approved by the U.S. Food and Drug Administration in 2003. The vaccine included in the MAA has not been registered in the European Union (EU) and is not available outside of the United States.
Influenza is the most common vaccine-preventable disease in the developed world. According to WHO estimates, seasonal influenza results in three to five million cases of severe illness and up to half a million deaths globally each year, primarily among the elderly. Rates of infection are highest among children, with school-aged children significantly contributing to spread of disease to their families, communities and high-risk individuals.
Influenza also has socioeconomic consequences related to both direct and indirect health care costs, including hospitalizations, work absence and loss of work productivity when either a caregiver or child is sick with influenza.
In the EU, current guidelines recommend annual influenza vaccination for the elderly as well as those with underlying medical conditions such as chronic heart or lung disease. However, vaccination rates in the recommended groups throughout Europe are estimated to be only 35 percent (Ryan, Vaccine, August 2006).
To date, six EU countries (Finland, Austria, Estonia, Latvia, Slovakia and Slovenia) recommend routinely vaccinating young children against influenza with varying age limits. EU and Member State policymakers continue to evaluate data on the impact of influenza in children to best inform the potential expansion of recommendations.
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. Dedicated to advancing science and medicine to help people live better lives, the company is focused on infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Headquartered in Gaithersburg, Maryland, MedImmune has approximately 3,000 employees worldwide and is the wholly owned biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN). For more information, visit MedImmune's website at http://www.medimmune.com.
Media, Chris Sampson, +44-(0)-207-304-5130, Sarah Lindgreen, +44-(0)-207-304-5033, both of AstraZeneca; Karen Lancaster of MedImmune, Inc., +1-301-398-5864; NOTE TO EDITORS: Attention: European Media -- Not intended for U.S. audiences