Natalizumab Withdrawal
On February 28, 2005, Biogen Idec and marketing partner Elan Pharmaceuticals voluntarily suspended marketing of natalizumab, and also suspended dosing in all ongoing clinical trials. Natalizumab had been approved in the US in November 2004 for treatment of patients with relapsing remitting MS.
The two companies announced the suspension after two participants involved in one study were diagnosed with a severe brain condition, progressive multifocal leukoencephalopathy (PML), after two years of combination therapy with Biogen's version of interferon beta-1a. One of those two patients died. Subsequently, another patient who had previously died in a separate clinical trial of natalizumab in patients with Crohns disease was re-evaluated as having had PML. In total, 3 cases of PML were identified, of which 2 cases were fatal.
On 08/2008 the company announced 2 more cases of PML in Europe.
Biogen Idec stock lost more than 40% of its value when the drug suspension news was released on February 28, 2005.
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Famous quotes containing the word withdrawal:
“A bizarre sensation pervades a relationship of pretense. No truth seems true. A simple morning’s greeting and response appear loaded with innuendo and fraught with implications.... Each nicety becomes more sterile and each withdrawal more permanent.”
—Maya Angelou (b. 1928)