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Lilly testosterone gel approved

Eli Lilly and Acrux have received US approval for Axiron, the first approved testosterone replacement therapy topically applied to the underarm

Lilly and the Australian drug-delivery company Acrux have received US Food and Drug Administration (FDA) approval for Axiron (testosterone), the first approved testosterone replacement therapy that is topically applied to the underarm.

The drug has been approved for use by men over the age of 18 who suffer from certain conditions associated with a deficiency or absence of testosterone,  including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

The product is an alcohol-based solution applied once daily using a metered dose applicator.

The marketing application for Axiron included phase III data from a 120-day clinical study showing that 84 per cent of men who completed the study achieved average serum testosterone concentration within the normal range. The most common adverse reactions were skin application site reactions, increased red blood cell count, headache, diarrhoea, vomiting and an increase in blood level of prostate specific antigen.

The labelling for Axiron will carry a boxed warning about the risks of secondary exposure to the drug. The warning states that Axiron can transfer from the patient's body to others who come into contact with the area where it was applied, and that contact with topical testosterone products has produced early signs of puberty in young children.

Under a deal that was signed while the Axiron marketing application was being reviewed by the FDA, Lilly obtained exclusive worldwide rights to commercialize the drug. The deal called for a $50m upfront payment, a $3m payment on the transfer of manufacturing assets, a milestone payment of up to $87m tied to FDA approval, up to $195m in potential commercialization milestones, and royalties on sales.

24th November 2010

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