Comments from Readers
Re: MS: Controlling Pain 2 of 2
This site contains valuable information. I agree with that communication is key to successful pain control. The PQRST ia popular way of measuring and describing pain. New research into MS pain will be helpful.
Re: BHT-3009 – Program Overview
Hello, you stated: “Second-line therapies for RR-MS are recommended for patients who inadequately respond to or cannot tolerate other therapies and include natalizumab (Tysabri sold by Biogen Idec Inc. and Elan Corporation, plc) and mitoxantrone (Novantrone marketed by EMD Serono, Inc.). Tysabri, an immune-modulating drug, is delivered intravenously once every four weeks at a registered infusion facility, but carries a risk of serious and sometimes fatal opportunistic infections. ”
This is not entirely accurate as it relates to Tysabri… Tysabri can & has been used as a first-line therapy, especially in cases of aggressive Progressive Relapsing were the treating neurologist does not wish to try the lesser effective ABCRs first.
See the following memorandum from the FDA which clarifies Tysabri’s use as a first line and/or second line therapy:
Clarification article by the FDA regarding Tysabri’s use as a first-line AND/OR second-line therapy for MS patients
First-line Tysabri therapy in some MS patients
MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
SUBJECT: Errata to FDA Background document for the Tysabri (natalizumab) Advisory Committee on July 31, 2007
In the reviews, Tab 1 (FDA Clinical Review) and Tab 2 (Office of Surveillance and Epidemiology Review), it was stated that the MS population to receive Tysabri should be those “unable to tolerate or with an inadequate response to other available MS therapies” and it was stated that the indication was revised to “relegate it [Tysabri] to a second-line therapy for relapsing-remitting MS.”
The indication in the current label states “…Tysabri is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternative multiple sclerosis therapies.”
FDA would like to clarify to the reader that the MS indication for Tysabri was carefully written by FDA and the Sponsor to indicate that its use is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternative multiple sclerosis therapies (e.g., as second-line therapy).
However, the indication statement does not explicitly preclude the possibility of first-line therapy in some MS patients as part of the approved use. FDA recognizes that the health care provider needs to consider its use based on the unique circumstances of each patient.
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4313b1-02-FDA-Errata.pdf
Furthermore, SPMS has two stages: with relapses-still in the inflammatory stage and qualifies for Tysabri; without relapses-progresses to the demyelinating stage and no longer qualifies for Tysabri at this time.
Respectfully submitted, Lauren
MS patient for 33 plus years & Tysabri patient for over two years
Note from Bonnie
Please check the bottom of the article it was compliments of Bayhill Therapeutics. Which means that I reported the article as they wrote it. I thank you very much for your clarification about Tysabri. I appreciate it.
