An recent article on Pharmaceutical Business Review states that MedImmune, the global biologics unit of AstraZeneca, has submitted a Marketing Authorisation Application (MAA) for its nasal spray live-attenuated seasonal influenza vaccine (LAIV) with the European Medicines Agency (EMEA). The vaccine is already marketed in the US under the brand name FluMist. The proposed indication in the MAA is for prevention of seasonal influenza and 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. However, MedImmune has not communicated the age range it is seeking approval for with the EMEA.
LAIV is a trivalent seasonal influenza vaccine which was first approved in the US in 2003 for use in individuals aged five to 49 years of age. In September 2007, the age range of the vaccine was extended by the FDA for use in children aged two to five years. However, this still only represents a small proportion of the key target population for seasonal influenza vaccination. The lack of approval in the elderly, the target group showing the highest seasonal flu vaccine coverage rates, has restricted the overall commercial potential of the vaccine, which only achieved sales of $53m in 2007.
The seasonal influenza vaccine market is a highly competitive field which is becoming increasingly commoditized as a result of the increasing number of available vaccines. Due to its intranasal mode of administration and very good efficacy in this age group, FluMist’s largest opportunity lies in the infant segment. However, it is questionable whether the cost-conscious European payers will opt to introduce FluMist readily following its European approval, if AstraZeneca decides to pursue a similar strategy as in the US, where the vaccine is marketed at a premium price compared to conventional seasonal influenza drugs.
In addition, seasonal flu vaccination in most European countries is currently largely restricted to the elderly population and does not cover the age group of two to 49 year olds, for which LAIV is approved in the US. Unless LAIV is approved for a wider age group than in the US, Datamonitor expects the overall commercial opportunity for the product in Europe to be limited.
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