Devastating news for Elan as third Tysabri patient death confirmed

There has been devastating news for Athlone-based pharmaceutical company Elan overnight after a safety evaluation of the drug Tysabri led to the revelation that a third patient using the drug had died.

Elan said the case had previously been diagnosed as malignant astrocytoma, but a reassessment revealed progressive multifocal leukoencephalopathy (PML, a rare infection of the brain and spinal cord) in a patient in a Crohn's disease clinical trial.

The news comes in the wake of two other PML-related deaths in patients using Tysabri. One patient was 38 months on the drug and the other 27. Both were using Tysabri in conjunction with another drug, Avonex.

Crucially, the patient in the latest case was being treated on Tysabri alone.

The company said today: "In the course of this safety review, the companies identified a case warranting reassessment in an open label Crohn's disease clinical trial. In July 2003, the case was reported by a clinical trial investigator as malignant astrocytoma. This diagnosis was confirmed at the time by histopathology. The patient died in December 2003.

"As part of this ongoing safety review, the companies, in agreement with the clinical trial investigator, reassessed the case. Following this additional evaluation, the diagnosis is being reassessed as PML."

The patient had received eight doses of Tysabri over an 18-month period.

Elan and its partner Biogen Idec are working with investigators to evaluate approximately 3,000 patients who took part in multiple sclerosis, Crohn's disease, and rheumatoid arthritis trials. The results will be discussed with regulatory agencies to determine possible re-initiation of dosing in clinical trials and future commercial availability.

It is likely though that, if Tybrasi is ever re-introduced, it will be in a much tighter capacity with additional warnings.