Tysabri multiple sclerosis clinical trial hold lifted by US FDA
http://www.pharmabiz.com/article/detnews.asp?articleid=31967
Thursday, February 16, 2006 16:00 IST
The Food and Drug Administration have removed the hold on clinical trial dosing of Tysabri (natalizumab) in multiple sclerosis (MS) in the US.
Biogen Idec and Elan Corporation plc can now resume clinical trial dosing in MS.
The two companies expect to begin an open label, multi-centre safety extension study of Tysabri monotherapy in the US and internationally in the coming weeks.
Biogen Idec and Elan had previously voluntarily suspended Tysabri from the US market and all ongoing clinical trials based on reports of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal, demyelinating disease of the central nervous system. Biogen Idec and Elan completed a comprehensive safety evaluation of more than 3,000 Tysabri patients in collaboration with leading experts in PML and MS. The results of the safety evaluation yielded no new confirmed cases of PML beyond the three previously reported, claims the company release.
On September 26, 2005 the companies submitted a supplemental biologics license application to the US FDA. Subsequently, the FDA designated Tysabri for priority review. The FDA grants priority review status to products that are considered to be potentially significant therapeutic advancements over existing therapies that address an unmet medical need.
Based on the FDA's designation of priority review for Tysabri in MS, the companies anticipate action by the agency approximately six months from the submission date, or by late March 2006. The FDA's Peripheral and Central Nervous System Drugs Advisory Committee will review Tysabri on March 7 and 8, 2006.
Thursday, February 16, 2006 16:00 IST
The Food and Drug Administration have removed the hold on clinical trial dosing of Tysabri (natalizumab) in multiple sclerosis (MS) in the US.
Biogen Idec and Elan Corporation plc can now resume clinical trial dosing in MS.
The two companies expect to begin an open label, multi-centre safety extension study of Tysabri monotherapy in the US and internationally in the coming weeks.
Biogen Idec and Elan had previously voluntarily suspended Tysabri from the US market and all ongoing clinical trials based on reports of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal, demyelinating disease of the central nervous system. Biogen Idec and Elan completed a comprehensive safety evaluation of more than 3,000 Tysabri patients in collaboration with leading experts in PML and MS. The results of the safety evaluation yielded no new confirmed cases of PML beyond the three previously reported, claims the company release.
On September 26, 2005 the companies submitted a supplemental biologics license application to the US FDA. Subsequently, the FDA designated Tysabri for priority review. The FDA grants priority review status to products that are considered to be potentially significant therapeutic advancements over existing therapies that address an unmet medical need.
Based on the FDA's designation of priority review for Tysabri in MS, the companies anticipate action by the agency approximately six months from the submission date, or by late March 2006. The FDA's Peripheral and Central Nervous System Drugs Advisory Committee will review Tysabri on March 7 and 8, 2006.
posted by Bill at 12:48 AM
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