More problems with Tysabri found
Both Biogen and Elan Corporation, the makers of now recalled Tysabri, may have more to hide than known to this day. In another startling development after Tysabri recall, the companies announced today that their ongoing safety evaluation of TYSABRI (natalizumab) has led to a previously diagnosed case of malignant astrocytoma being reassessed as progressive multifocal leukoencephalopathy (PML), in a patient in an open label Crohn's disease clinical trial.
This is a major setback to the chance that Tysabri will ever come back on the market since this development essentially shows that the problem with Tysabri is worse than originally believed. In fact, some analysts were so optimistic initially that they forecast that Tysabri may be back on the market within 2005.
Since the suspension of Tysabri sales was announced, the companies have been forced to do damage control by investigating their trials. 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 8 doses of TYSABRI over an 18 month period and prior medication history included multiple courses of immunosuppressant agents.
It is important to note here that one Biogen executive has left the company when suspicions about insider trading surfaced. Both Elan and Biogen have suffered massive loss in market value and it is expected that Elan will be split into several pieces. Similarily Biogen, which is accused of being hyping a combination of Avonex and Tysabri, may also find it difficult to recover from this setback. (Related article: No Avonex recall yet though link shown to liver damage)
Elan and Biogen Idec's comprehensive safety evaluation concerning TYSABRI and any possible link to PML is ongoing. The companies are reviewing clinical trial data, working with investigators to evaluate the approximately 3,000 patients in multiple sclerosis, Crohn's disease, and rheumatoid arthritis trials, and working with PML and neurology experts. The results of this safety evaluation will be discussed with regulatory agencies to determine possible re-initiation of dosing in clinical trials and future commercial availability.
Related article: Tysabri recall class action lawsuit
This is a major setback to the chance that Tysabri will ever come back on the market since this development essentially shows that the problem with Tysabri is worse than originally believed. In fact, some analysts were so optimistic initially that they forecast that Tysabri may be back on the market within 2005.
Since the suspension of Tysabri sales was announced, the companies have been forced to do damage control by investigating their trials. 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 8 doses of TYSABRI over an 18 month period and prior medication history included multiple courses of immunosuppressant agents.
It is important to note here that one Biogen executive has left the company when suspicions about insider trading surfaced. Both Elan and Biogen have suffered massive loss in market value and it is expected that Elan will be split into several pieces. Similarily Biogen, which is accused of being hyping a combination of Avonex and Tysabri, may also find it difficult to recover from this setback. (Related article: No Avonex recall yet though link shown to liver damage)
Elan and Biogen Idec's comprehensive safety evaluation concerning TYSABRI and any possible link to PML is ongoing. The companies are reviewing clinical trial data, working with investigators to evaluate the approximately 3,000 patients in multiple sclerosis, Crohn's disease, and rheumatoid arthritis trials, and working with PML and neurology experts. The results of this safety evaluation will be discussed with regulatory agencies to determine possible re-initiation of dosing in clinical trials and future commercial availability.
Related article: Tysabri recall class action lawsuit
posted by eCreativa Media | 11:53 AM 
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