Friday, 20 September 2013
AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on Fluenz Tetra, a nasally administered four-strain live attenuated influenza vaccine, for the prevention of seasonal influenza in eligible children and adolescents 24 months to 17 years of age.
Historically, seasonal flu vaccines have contained three strains of influenza: one influenza A (H1N1) virus, one influenza A (H3N2) virus, and one influenza B virus. However, Fluenz Tetra contains two strains of influenza A and two strains of influenza B to provide broad protection against influenza B. Influenza B strains on average account for approximately 25 percent of the influenza strains that circulate in Europe.
The positive opinion was reached after a review of data from a pivotal paediatric study. These data indicated that the safety and immunogenicity profile of Fluenz Tetra was comparable to currently approved three-strain (trivalent) vaccine, Fluenz.
Filip Dubovsky, Vice President of Clinical Biologics Infectious Disease and Vaccines, MedImmune, AstraZeneca's global biologics research and development arm, said: "We are delighted that Fluenz Tetra has received a positive opinion from the CHMP. The inclusion of two influenza B strains in the vaccine will provide broad protection and should help to reduce the overall incidence of influenza."
The CHMP's positive opinion on Fluenz Tetra will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. Should the EC approve Fluenz Tetra, it will replace Fluenz from the 2014-2015 flu season onwards.
NOTES TO EDITORS
About Fluenz Tetra
Fluenz Tetra is formulated to contain four live attenuated influenza virus strains that are weakened so as to not cause illness. The vaccine is administered by spraying into each
nostril where it induces protective immunity. The most common adverse reactions for Fluenz Tetra include runny nose or nasal congestion.
In the US, Fluenz Tetra is marketed by MedImmune Specialty Care Division of AstraZeneca, under the trade name FluMist® Quadrivalent (Influenza Vaccine Live, Intranasal). FluMist Quadrivalent was approved by the US Food and Drug Administration on 29 February 2012.
About Tetravalent Influenza Vaccines
Vaccine strains are recommended annually by the World Health Organization (WHO) based on anticipated circulating influenza strains for the upcoming season. Historically, seasonal flu vaccines have been trivalent formulations, meaning they contain three strains of influenza: one influenza A (H1N1) virus, one influenza A (H3N2) virus, and one influenza B virus. However, new tetravalent (also referred to as quadrivalent) flu vaccines contain two strains of influenza A and two strains of influenza B to provide broad protection against influenza B.
Since 2001, influenza B strains from two different lineages (B/Yamagata and B/Victoria) have co-circulated each influenza season in Europe. Trivalent vaccine formulations rely on predictions of which influenza B strains will be dominant in the upcoming season. However, B strain circulation has been difficult to predict correctly, and in recent years, the vaccine B strain did not match the dominant circulating B strain.
About MedImmune
MedImmune is the worldwide biologics research and development arm of AstraZeneca. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca's three global R&D centers. For more information, please visit www.medimmune.com
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com
CONTACTS
Media Enquiries
Esra Erkal-Paler +44 20 7604 8030 (UK/Global)
Vanessa Rhodes +44 20 7604 8037 (UK/Global)
Tracy Rossin +1 301 398 1468 (MedImmune)
Jacob Lund +46 8 553 260 20 (Sweden)
Investor Enquiries
Ed Seage +1 302 886 4065 mob: +1 302 373 1361
Karl Hård +44 20 7604 8123 mob: +44 7789 654364
Colleen Proctor +1 302 886 1842 mob: +1 302 357 4882
Anthony Brown +44 20 7604 8067 mob: +44 7585 404943
Jens Lindberg +44 20 7604 8414 mob: +44 7557 319729