AstraZeneca hitch
AstraZeneca has suffered its second blow in the US in a matter of days.
The US Food and Drug Administration has demanded more information on the company’s asthma treatment Symbicort before clearing it for use by young children. It said information provided was inadequate to establish the correct dosage for patients aged between six and 11.
Symbicort is already sold in the US to asthma and emphysema sufferers over the age of 12. It competes against GlaxoSmithKline’s Advair, which is used by children as young as four.
Symbicort is AstraZeneca’s fourth largest drug in terms of revenue, achieving sales of $2billion last year compared to Advair’s $6billion.
Although the FDA’s objections will likely only delay approval by the regulator, analysts say the news is negative for the company as sales of the product have already under-performed. It follows news late last week that the FDA expressed concern over whether to approve expansion of AstraZeneca’s antipsychotic drug Seroquel.