As you know, the FDA is currently reviewing Marathon Pharmaceutical’s New Drug Application (NDA) for deflazacort for the treatment of Duchenne. It is our understanding that a decision is expected to be made by Marathon’s PDUFA date -- February 9, 2017.
If an approval decision occurs, and you are currently ordering deflazacort from outside the United States, there will be changes to how you are able to access the drug. If you are currently ordering deflazacort through Masters Specialty Pharma, Masters will only be able to continue supplying you with deflazacort until Marathon makes their own newly approved deflazacort commercially available.
Masters recently sent a letter to patients detailing how you can sign up for the Deflazacort Transition Program in order to ensure continuity of your deflazacort supply. Read a copy of the latest communication from Masters below.
Communication From Masters:
IMPORTANT REMINDER REGARDING YOUR SUPPLY OF DEFLAZACORT—YOU MAY NEED TO TAKE ACTION TO ENSURE DEFLAZACORT SUPPLY IN THE FUTURE
As you may recall, we originally notified you in October 2016 of some changes affecting the future supply of deflazacort to Masters Customers in the US. Subject to FDA approval and product registration, deflazacort will be available to patients in the US suffering from Duchenne Muscular Dystrophy (DMD), thereby allowing widespread access to the drug throughout the US. We therefore thought that this an opportune time to to provide you with an update regarding the potential FDA approval process and to reiterate the steps you need to take to help ensure continuity of your deflazacort supply.
Based on the timing of the filing of Marathon’s New Drug Applications (NDAs) for the immediate-release tablet and oral suspension formulations of deflazacort, an approval decision is expected to be made by the FDA by February 9, 2017. If such approval does occur, Masters will only be able to continue supplying you with deflazacort until Marathon makes their own newly approved deflazacort commercially available, which we anticipate will be within approximately six (6) weeks of the FDA’s estimated approval date of February 9, 2017, and therefore potentially available in late March, 2017.
Marathon have given their commitment to clearly communicate to Masters the status of the commercial availability of their own deflazacort brand, and we will ensure that you remain informed of when Masters will no longer be able to supply its deflazacort to patients in the US.
Summarized below are the steps you need to take (if you haven’t already done so) to ensure you receive deflazacort from Marathon after its commercial launch of FDA-approved deflazacort:
1. Visit the Deflazacort Information Center website at www.deflazacort.us; ;
2. Review the website information about deflazacort;
3. Speak with your physician about your continued use of deflazacort; and
4. Sign up for the Deflazacort Transition Program by completing the online form in order to ensure that you are notified of Marathon’s deflazacort registration in the U.S. and other steps you need to take in order to ensure you can obtain Marathon’s deflazacort.
Subject to your consent, Masters will send your patient or caregiver and prescription information to Marathon’s Deflazacort Information Center. The Deflazacort Information Center can be accessed at www.deflazacort.us, and the site offers further information on providing your consent, if you choose to do so. Your consent will authorise Marathon to receive the information they need from Masters to facilitate your access to their deflazacort subject to its approval by the US FDA.
It is our understanding that Marathon plans to have the most comprehensive and robust patient support programs allowed under US law in place to provide patients suffering from DMD that require deflazacort access to Marathon’s product when it is approved by the FDA. If you have any questions, please feel free to contact Marathon’s Medical/Scientific Affairs Department at (847) 715-0699 or via email at email@example.com.
Masters has been pleased and proud to provide the personal service that we have offered for many years to the DMD patients and their families. If you have any questions regarding the changes described in this letter, please don’t hesitate to contact the Masters team through the contact information provided directly below or the Marathon team through the contact information provided in the previous paragraph:
Masters Pharmaceuticals Limited: 1-800-969-1152, or via email at firstname.lastname@example.org.
Heather J Gamble
Business Marketing Director