New Ty News
Boost for Elan's Tysabri from FDA report
Wednesday, March 23 15:56:17 (BizWorld)
In a boost for troubled Irish pharma company, Elan, the US Food and Drug Administration (FDA) today said it had found no post-marketing reports of PML in MS patients who were given Elan's Tysabri drug. Elan said two recently reported cases of progressive multifocal leukoencephalopathy (PML) in multiple sclerosis (MS) patients receiving interferon beta therapy in combination with TYSABRI (natalizumab), the United States Food and Drug Administration (FDA) has now analysed its post-marketing safety database.
The FDA statement said: FDA has analysed data in its post-marketing database and not found any cases of PML reported in patients receiving a beta-interferon."Elan's partner, Biogen, said today that the finding supports its ongoing reviews of safety databases by a panel of experts convened in the US. This also revealed no previously reported cases of PML in MS patients treated with interferon beta monotherapy.
A joint Elan-Biogen statement said it remains unclear why PML developed in the two patients treated with this combination therapy."Biogen Idec and Elan Pharmaceuticals are continuing their extensive evaluation of natalizumab-treated patients in clinical trials and remain in close contact with both the FDA and other international Regulatory Authorities, as well as advisory and safety monitoring committees for the clinical trials of natalizumab. Because of the importance of these cases and the promising efficacy data reported to date with natalizumab, Biogen Idec and Elan are working together to complete this review process as thoroughly and quickly as possible," the statement said.
Wednesday, March 23 15:56:17 (BizWorld)
In a boost for troubled Irish pharma company, Elan, the US Food and Drug Administration (FDA) today said it had found no post-marketing reports of PML in MS patients who were given Elan's Tysabri drug. Elan said two recently reported cases of progressive multifocal leukoencephalopathy (PML) in multiple sclerosis (MS) patients receiving interferon beta therapy in combination with TYSABRI (natalizumab), the United States Food and Drug Administration (FDA) has now analysed its post-marketing safety database.
The FDA statement said: FDA has analysed data in its post-marketing database and not found any cases of PML reported in patients receiving a beta-interferon."Elan's partner, Biogen, said today that the finding supports its ongoing reviews of safety databases by a panel of experts convened in the US. This also revealed no previously reported cases of PML in MS patients treated with interferon beta monotherapy.
A joint Elan-Biogen statement said it remains unclear why PML developed in the two patients treated with this combination therapy."Biogen Idec and Elan Pharmaceuticals are continuing their extensive evaluation of natalizumab-treated patients in clinical trials and remain in close contact with both the FDA and other international Regulatory Authorities, as well as advisory and safety monitoring committees for the clinical trials of natalizumab. Because of the importance of these cases and the promising efficacy data reported to date with natalizumab, Biogen Idec and Elan are working together to complete this review process as thoroughly and quickly as possible," the statement said.
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