CHMP revises Fabrazyme recommendations

The European Medicines Agency's CHMP said newly identified Fabry's disease patients in Europe should be given an alternative treatment to Fabrazyme agalsidase beta from Genzyme Corp. (NASDAQ:GENZ), such as Replagal agalsidase alfa from Shire plc (LSE:SHP; NASDAQ:SHPGY). EMA's CHMP also said patients receiving less than 1 mg/kg Fabrazyme every other week should be evaluated for alternative treatment. Patients receiving 1 mg/kg Fabrazyme every other week should continue treatment. In April, CHMP recommended switching to Replagal as an option for patients receiving a reduced dose of Fabrazyme who show a deterioration of disease (See BioCentury Extra, Friday, April 23, 2010).

CHMP said it issued the update after receiving information from Genzyme that the current supply of Fabrazyme will not address patients' needs in Europe. Genzyme said last week that it expects supply of the drug to "be tight" in July and August, adding that "from July through September many regions will see periods where Fabrazyme will be unavailable." The drug has faced supply shortages since June 2009 due to viral contamination and other problems at the company's Allston, Mass., facility. In April, the company had said it expected to continue to ship to meet 30% of demand through 3Q10 (See BioCentury Extra, Wednesday, April 21, 2010). ...