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 been experiencing side effects and progression of their disease, the European Medicines Agency says in a statement.
But supplies of Fabrazyme, which ran scarce after serious trouble at a Genzyme manufacturing plant, aren't expected to rebound completely until the second half of next year, the agency says. Supply of the drug doubled in the U.S. last month, to 60 percent of normal; next quarter, the global supply is expected to reach similar levels, Genzyme recently disclosed.
The EMA now says that, while some patients do well on the reduced dose, it's seeing an increase in health problems among many patients. "At first, most of the events were pain-related, soon followed by reports of events affecting the heart, the central nervous system and the kidneys," the agency explains in a statement. "This pattern suggests a progression of Fabry disease."
The EMA's recommendation could push more patients to try Shire's competing product Replagal.
- see the EMA release
- read the Reuters story