Shire receives FDA priority review for velaglucerase alfa

Shire revealed this week that the Food and Drug Administration (FDA) has granted priority review status to its type 1 Gaucher therapy velaglucerase alfa.

The enzyme replacement therapy’s new drug application has now been issued a definite action date of February 28th 2010 under the Prescription Drug User Fee Act.

Priority review is given to therapies that have the potential to offer major advances in treatment, or provide a drug where no adequate therapy exists.

It also reduces the target review timing from ten to six months.

Velaglucerase alfa supplements or replaces beta-glucocerebrosidase – the enzyme that catalyses the hydrolysis of glucocerebroside – reducing the amount of accumulated glucocerebroside and correcting the pathophysiology of Gaucher disease.

Earlier this week, Shire published its financial results for the third quarter of 2009, revealing that sales of existing products rose by 20 per cent to $531.6 million (322.9 million pounds), compared to $443.8 million during the same period of 2008.