Conditions under which Tysabri will come back to market

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

Conditions under which Tysabri will come back to market

Postby OddDuck » Sun Apr 02, 2006 9:09 am

I posted this in another thread just now, but figured it might need it's own thread. This is a March 27th update regarding the return of Tysabri:

http://www.nationalmssociety.org/tysabri_march8.asp

Excerpt:

"....Its key recommendations for approval include:

• Tysabri be made available only to patients who have enrolled along with their physicians in a mandatory registry program;

• Tysabri be made available only to patients diagnosed with relapsing MS;

• Tysabri could be considered appropriate for use in MS patients who experience relapses regardless of their degree of disability, so that even persons with no disability or severe disability would be eligible;

• Tysabri be given only at authorized infusion centers where the medical personnel have been trained in its proper use and in the risks of PML;

• Tysabri not be used in patients who have compromised immune systems or who are taking other immunosuppressive or immunomodulatory agents, with the possible exception of periodic steroids to treat relapses;

• prescribing information carry a “black box warning” concerning PML;

• prior to starting treatment, the physician complete a “patient checklist” to ensure that the patient meets all requirements for use of Tysabri; and

• prior to each infusion, the patient and infusion nurse complete a checklist to screen for symptoms suggestive of PML.

The advisory committee did not achieve consensus on any recommendation of whether Tysabri should be used as a “first-line” therapy or whether a patient must first be on another disease-modifying therapy that proved ineffective. ...."

User avatar
OddDuck
Contributing Author
 
Posts: 1040
Joined: Sat Jun 19, 2004 3:00 pm
Location: Tennessee

Advertisement

Re: Conditions under which Tysabri will come back to market

Postby HarryZ » Mon Apr 03, 2006 5:27 am

Deb,

This is the same drug that was rushed through the approval process and released to the general public last January (2005), wasn't it? :?

Harry
User avatar
HarryZ
Family Elder
 
Posts: 2321
Joined: Tue May 25, 2004 3:00 pm
Location: London, ON, Canada

Postby OddDuck » Tue Apr 04, 2006 10:59 am

Yep. Sure was, Harry! The one we were saying "Wait, wait! Slow down!"

Oh well, I'm used to not being listened to. Hence my last two divorces! :lol:
User avatar
OddDuck
Contributing Author
 
Posts: 1040
Joined: Sat Jun 19, 2004 3:00 pm
Location: Tennessee

Risk Control Plan Key To Natalizumab's Return

Postby better2gether » Wed Apr 05, 2006 1:46 am

.
Risk Control Plan Key To Natalizumab's Return

ELIZABETH MECHCATIE (Senior Writer)

http://www.clinicalneurologynews.com/ar ... 4/fulltext
.
User avatar
better2gether
Family Elder
 
Posts: 188
Joined: Sun Dec 19, 2004 4:00 pm


Return to Tysabri (Antegren or Natalizumab)

 


  • Related topics
    Replies
    Views
    Last post

Who is online

Users browsing this forum: No registered users