Neuroscience
From the FDA:
Information on Natalizumab (marketed as Tysabri)
Updated Information: [9/2009]
The FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri. Tysabri was approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in November 2004 and for moderately to severely active Crohn’s disease in January 2008. From July 2006, (when Tysabri marketing resumed) to September 8, 2009, 13 reported cases of Tysabri-related PML were confirmed worldwide in patients being treated for MS with Tysabri monotherapy. Of these, four cases were patients in the United States (U.S.). There have been no postmarketing reports of PML in patients treated with Tysabri for Crohn’s disease. Less than 2% of Tysabri use in the U.S. has been in patients with Crohn's disease.
The risk for developing PML appears to increase with the number of Tysabri infusions received. The number of monthly infusions of Tysabri in the 13 patients who developed PML ranged from 12 to 35 infusions. The average number of infusions received before the diagnosis of PML was 25. There is minimal experience in patients who have received more than 35 infusions of Tysabri.
The overall rate of developing PML with Tysabri therapy in patients who have received at least one infusion remains below one per 1,000 patients. Based on available data from the U.S. and outside of the U.S., the current rate of PML in patients who have received at least 24 infusions ranges from 0.4 to 1.3 per 1,000 patients.
At this time, the FDA is not requiring changes regarding PML to the Tysabri prescribing information or to the Tysabri risk management plan, called the TOUCH Prescribing Program. All patients receiving Tysabri therapy in the U.S. must be enrolled in the TOUCH Prescribing Program. Under this program, every patient who receives Tysabri is closely monitored for the occurrence of PML and other serious opportunistic infections.
Read the Update
- Fda: Progressive Multifocal Leukoencephalopathy (pml) And Tysabri (natalizumab)
From the FDA: FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri For Immediate Release: January 20, 2012 [snip]"Today, the U.S. Food and Drug Administration allowed marketing of the first test to...
- Business World: Biogen Idec, Elan, & Tysabri (natalizumab) And Ms
From the FDA: FOR IMMEDIATE RELEASE P06-25 February 16, 2006 Media Inquiries: Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Allows Clinical Studies of Tysabri (natalizumab) for Treatment of MS to Proceed The Food and...
- Business World: Biogen Idec, Elan, & Tysabri (natalizumab)
From today's Boston Globe:Biogen MS drug gets lift from reports Medical journal suggests Tysabri may make a return By Jeffrey Krasner The Boston Globe 10 June 2005 Biogen Idec Inc.'s drug Tysabri might be safely given to multiple sclerosis patients...
- Tysabri (natalizumab): Another Case Of Pml
A third case of progressive multifocal leukoencephalopathy (PML), as reported via The New York Times website: M.S. Drug Tied to a Death Published: March 31, 2005 By Bloomberg News Biogen Idec and the Elan Corporation said that a third patient had developed...
- Post Tysabri (natalizumab): What Choices In M.s. Treatment?
The Consumer: Exploring Choices for M.S. By MARY DUENWALD The New York Times 15 March 2005 [snip] An estimated 5,000 patients who had been taking Tysabri since the Food and Drug Administration approved it in late November are now advised to see their...
Neuroscience
FDA: Updated Info on Tysabri (Natalizumab)
From the FDA:
Information on Natalizumab (marketed as Tysabri)
Updated Information: [9/2009]
The FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri. Tysabri was approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in November 2004 and for moderately to severely active Crohn’s disease in January 2008. From July 2006, (when Tysabri marketing resumed) to September 8, 2009, 13 reported cases of Tysabri-related PML were confirmed worldwide in patients being treated for MS with Tysabri monotherapy. Of these, four cases were patients in the United States (U.S.). There have been no postmarketing reports of PML in patients treated with Tysabri for Crohn’s disease. Less than 2% of Tysabri use in the U.S. has been in patients with Crohn's disease.
The risk for developing PML appears to increase with the number of Tysabri infusions received. The number of monthly infusions of Tysabri in the 13 patients who developed PML ranged from 12 to 35 infusions. The average number of infusions received before the diagnosis of PML was 25. There is minimal experience in patients who have received more than 35 infusions of Tysabri.
The overall rate of developing PML with Tysabri therapy in patients who have received at least one infusion remains below one per 1,000 patients. Based on available data from the U.S. and outside of the U.S., the current rate of PML in patients who have received at least 24 infusions ranges from 0.4 to 1.3 per 1,000 patients.
At this time, the FDA is not requiring changes regarding PML to the Tysabri prescribing information or to the Tysabri risk management plan, called the TOUCH Prescribing Program. All patients receiving Tysabri therapy in the U.S. must be enrolled in the TOUCH Prescribing Program. Under this program, every patient who receives Tysabri is closely monitored for the occurrence of PML and other serious opportunistic infections.
Read the Update
- Fda: Progressive Multifocal Leukoencephalopathy (pml) And Tysabri (natalizumab)
From the FDA: FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri For Immediate Release: January 20, 2012 [snip]"Today, the U.S. Food and Drug Administration allowed marketing of the first test to...
- Business World: Biogen Idec, Elan, & Tysabri (natalizumab) And Ms
From the FDA: FOR IMMEDIATE RELEASE P06-25 February 16, 2006 Media Inquiries: Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Allows Clinical Studies of Tysabri (natalizumab) for Treatment of MS to Proceed The Food and...
- Business World: Biogen Idec, Elan, & Tysabri (natalizumab)
From today's Boston Globe:Biogen MS drug gets lift from reports Medical journal suggests Tysabri may make a return By Jeffrey Krasner The Boston Globe 10 June 2005 Biogen Idec Inc.'s drug Tysabri might be safely given to multiple sclerosis patients...
- Tysabri (natalizumab): Another Case Of Pml
A third case of progressive multifocal leukoencephalopathy (PML), as reported via The New York Times website: M.S. Drug Tied to a Death Published: March 31, 2005 By Bloomberg News Biogen Idec and the Elan Corporation said that a third patient had developed...
- Post Tysabri (natalizumab): What Choices In M.s. Treatment?
The Consumer: Exploring Choices for M.S. By MARY DUENWALD The New York Times 15 March 2005 [snip] An estimated 5,000 patients who had been taking Tysabri since the Food and Drug Administration approved it in late November are now advised to see their...