May 10, 2017

Dear ALS Clinic Participant:

As you may have heard, the FDA recently approved a new medication for the treatment of amyotrophic lateral sclerosis (ALS).  This is called Radicava (edaravone). In small study lasting 6 months, Radicava was observed to slow the progression of ALS (in some patients this may slow progression by 33%). Radicava is given intravenously over one hour. Initially Radicava is given daily for 14 days. You are then off the medicine for 14 days. Thereafter, Radicava is given 10 days every month over 14 days, then you are off medicine for 14 days. As of now, treatment is indefinite.

The company that makes Radicava, MT Pharma, says the drug will be available in August 2017. A year’s treatment is estimated to cost $146,000. We do not yet know how easy or difficult it will be to get insurance companies to approve Radicava or what patient’s costs will be. MT Pharma says they will have options for patients who do not have insurance. Radicava can be taken in combination with Rilutek (riluzoke) but this is not necessary. There have not been reports of interactions with any medications.

We envision you would get Radicava at home, given by a home health nurse. Given the large number of IV’s you will need over time, the best strategy is to get some sort of special IV line that can stay in place for months or even much longer. This will need to be decided on a case-by-case basis.

The most common adverse effects observed with treatment are bruising, trouble walking, headache, and rash. People with asthma or sensitivity to something called sulfites could develop breathing problems after infusion with Radicava.

We recommend you visit MT Pharma’s website www.radicava.com for further information.

This is certainly a potentially exciting time but we understand there are many logistical aspects we do not yet know. The team at the Phoenix Neurological Associates ALS Clinic remains committed to helping you with this process as best as we can. We will provide more information when we have it.

Sincerely,

 

Todd Levine, MD                                              David Saperstein, MD