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news.The FDA has granted an additional six-month period of exclusivity to market AstraZeneca's Arimidex for its licensed breast cancer indications until June 2010. Prior to pediatric exclusivity being granted by the FDA, the patent was due to expire in December 2009.
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Although the drug is not approved for children, the company said that the FDA has granted the patent extension in recognition of its Arimidex pediatric studies. AstraZeneca had submitted a proposed pediatric study to the FDA in 1999.
John Patterson, executive director of development at AstraZeneca, said: “Preclinical and clinical data supported the investigation of the therapeutic potential of Arimidex in pediatric conditions that manifest symptoms resulting from increased estrogen production, for example: gynecomastia in pubertal boys and precocious puberty in girls with McCune-Albright Syndrome.
“While pleased to have been able to work with the FDA in investigating the potential benefits of Arimidex in these settings, AstraZeneca will not be seeking an indication in either of these pediatric conditions based on trial results.”