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UPDATE 1-Shire asks EU for Gaucher drug approval
November 24, 2009 / 12:49 PM / 8 years ago

UPDATE 1-Shire asks EU for Gaucher drug approval

* Shire rushing to get approval before rival drug runs out

* Drug was submitted to U.S. authorities in September (Adds details)

LONDON, Nov 24 (Reuters) - Britain’s Shire (SHP.L) has asked the EU to officially allow people to take its new Gaucher disease drug, it said on Tuesday, providing hope to sufferers of the disease as supplies of a rival drug start to run out.

The approval process became a race against time after Genzyme GENZ.O was forced to cease production of the main drug for the disease, Cerezyme, when its manufacturing site became infected with a virus. [ID:nN16267721]

Shire has submitted a Marketing Authorisation Application to the European Medicines Agency which, like its U.S. counterpart the Food and Drug Administration, has agreed to fast track the application for the drug, known as velaglucerase alfa.

The fast track will cut approval times from 210 days to 150 days in Europe for the drug, which is already being given to some patients through a pre-approval access program.

Shire plans to provide velaglucerase alfa initially free of charge in order to give suffers of Gaucher, which results from a deficiency of an enzyme, access to the medicine as quickly as possible.

However, the problems at Genzyme will help Shire’s long-term plans for the drug as under normal circumstances Gaucher patients rarely change the drug they use, analysts say.

The drug was submitted to U.S. authorities in September. [ID:nL1540086]

Reporting by Ben Deighton ben.deighton@reuters.com; +44 207 542 7009; ben.deighton.reuters.com@reuters.net

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