Shire files for Gaucher drug in Europe
pharmafile | December 1, 2009 | News story | Sales and Marketing |Â Â Cerezyme, Gaucher, ShireÂ
Shire has followed up its marketing applications for Gaucher disease treatment velaglucerase alfa in the US and Canada with a submission to the European Medicines Agency.
Velaglucerase alfa has been on the fast-track to market since the only approved drug for Gaucher disease, Genzyme’s Cerezyme (imiglucerase), was beset by a string of manufacturing problems that have led to widespread shortages.
As a result, velaglucerase alfa will be given an accelerated assessment by the EMEA’s Committee for Medicinal Products for Human Use (CHMP), cutting the review time to 150 days from the usual 210. The review process is expected to get underway next month.
Meanwhile, in the US, the deadline for a Food and Drug Administration (FDA) verdict on the velaglucerase marketing application is on February 28, 2010, and the company is hopeful of being able to launch there before the end of the first quarter.
Patients with Gaucher disease are already receiving velaglucerase alfa in Europe, the US and a number of countries under emergency access programmes that allow investigational drugs to be used ahead of regulatory approval.
Shire’s chief executive Angus Russell said Shire has been working hard to get up to speed with velaglucerase alfa’s manufacturing capacity, and is now running around 18 months ahead of its planned schedule before the Cerezyme shortages prompted regulators to ask for early access to the drug.
“We’re doing everything we can to provide as much material as we can as quickly as possible,” said Russell.
Shire has said it has production capacity to serve the requirements of 300 and 600 patients, depending on the dose they use, and expects to be treating that many by the end of the year. The dose ranges being used in the market at present range from 15mg to 60mg.
Another company benefitting from Genzyme’s manufacturing misfortunes is Protalix Biotherapeutics. That company’s treatment protocol for pGCD, another candidate for Gaucher disease treatment, was also approved by the FDA recently.
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