European regulators are advising doctors to consider switching Fabry disease patients to Shire's new treatment Replagal as shortages of Genzyme's Fabrazyme continue. The European Medicines Agency says that Fabrazyme supplies are expected to run short until the end of September, and some patients aren't doing well on a low-dose regimen advised last year.
Genzyme has been been in a state of turmoil for almost a year. Manufacturing troubles led to a shutdown of a key Boston plant, which caused supplies of Cerezyme (for Gaucher disease) and Fabrazyme to run short. The company has been struggling ever since to get the plant back to full production. And just this week, Genzyme announced it expects a $175 million fine from the FDA as it prepares to operate under a consent decree with the agency.
All of this trouble has opened the door to rival treatments, particularly Shire's Replagal, which FDA made available to patients to help quell shortages of Fabrazyme. The drug has been approved for use in Europe since 2001, but hasn't yet won U.S. approval.
Now, here's another chance for Shire to grab market share. The EMEA's new guidance on Fabry disease treatment comes as some 12 percent of patients on lower doses of Fabrazyme have seen their disease worsen. The agency is recommending a new dosing schedule, advising that patients who don't do well on the lower doses should restart therapy at a higher dose--or switch to Replagal. No reaction yet from Genzyme.
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