In a surprising turn of events, Shire ( $SHPGY ) announced late yesterday that it is jerking its application for Replagal, the rare genetic disorder drug that the FDA had pushed to get on the market as Genzyme sorted out its high-profile manufacturing problems. The reason for the sudden reversal? The FDA is indicating the need for new clinical studies before it stamps an OK on the treatment for Fabry disease. And that put any approval off to "the distant future," the company said.
Sanofi ( $SNY ) may want to thank its lucky stars that its new Genzyme plant won FDA approval when it did. The facility in Framingham, MA, will allow the French drugmaker's rare-disease unit to get back on track with its Fabry disease drug Fabrazyme . It may also have deterred Shire from pursuing its own Fabry drug application in the face of complications at the FDA.
Shire 's rare-disease challenge is heating up.
Shire ( $SHPGY ) bucked fourth-quarter trends with a 47% increase in earnings and expectations for continued growth in the coming year. At a time when most of Big Pharma was suffering declining Q4...
Shire unveiled top-line data from new studies suggesting it's safe for Fabry disease patients to switch to Replagal from Genzyme's Fabrazyme, which has been running scarce for some time. In addition,
Shire has won European approval for its new manufacturing site in the U.S., allowing the U.K. company to ramp up production of its products, including Replagal for Fabry disease. Report
European regulators want Fabry disease patients to go back on their full doses of Fabrazyme. Patients who have been taking a reduced dose--required because of short supplies of the Genzyme drug--have
There's at least one entity who is benefiting from Genzyme's ongoing manufacturing woes, and that's Shire. Since the closure of a plant touched off shortages of Genzyme's drugs, Shire's rival meds
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