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Date: 2011-12-19

Type of information: Granting of a Market Authorisation in the EU

Product name: Fluenz® Tetra/FluMist® Quadrivalent

Compound: nasally administered four-strain live attenuated influenza vaccine

Therapeutic area: Infectious diseases

Action mechanism:

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.This flu vaccines contains four strains of influenza: two influenza A viruses (H1N1 and H3N2) and two influenza B virus. The most common adverse reactions for Fluenz Tetra® include runny nose or nasal congestion. In the US, it 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 FDA on 29 February 2012.

Company: AstraZeneca (UK)

Disease:

prevention of seasonal influenza in eligible children and adolescents 24 months to 17 years of age

Latest news:

* On December 6, 2013, AstraZeneca has announced that the European Commission has granted Marketing Authorisation to Fluenz® Tetra. Fluenz Tetra® is a nasally administered four-strain live attenuated influenza vaccine for the prevention of influenza in children and adolescents from 24 months up to 18 years of age. The EC approval makes Fluenz Tetra® the first and only intra-nasal four-strain influenza vaccine available in Europe.
The Marketing Authorisation of Fluenz® Tetra is based on data from a pivotal paediatric study. Findings showed that Fluenz Tetra® demonstrated a safety and immunogenicity profile that was comparable to Fluenz™, a three-strain (trivalent) live attenuated influenza vaccine already approved in Europe.
The EC decision follows a positive opinion from the Committee for Medicinal Products for Human Use on 19 September 2013, and is applicable to all 28 member states and the three European Economic Area countries of the European Union.
* On September 20, 2013AstraZeneca has 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. Should the EC approve Fluenz Tetra, it will replace Fluenz from the 2014-2015 flu season onwards.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization: 2012-02-29

UE authorization: 2013-12-06

Favourable opinion UE: 2013-09-20

Favourable opinion USA:

Orphan status USA:

Orphan status UE: 2013-09-19

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes