Monday, October 18, 2010

Critical Information about FDA Approval of Benlysta for Lupus

I am just adding this information about the FDA and the pending approval of a one of its kind, very first Lupus Medication Benlysta. I have been following the clinical trials and all of the information about it now for at least 3 years, awaiting the day it is formally approved and I can have my first infusion hopefully. If any of you are Lupus victims, know someone with Lupus, or just are an advocate voice, here is a portion of the newsletter I get from It contains an email address where you can email your thoughts, comments and encouragement to one of the FDA members that will have some weight about getting the medication approved. Thanks so much for all of your incredible support for myself and so many others...

Here is the article:

Here is a portion of the newsletter I get from It has the email address of one of the women at the FDA who will have something to do
with Benlysta, the brand new Lupus medication, first ever of its kind,
FDA approved by Dec 9th 2010!! Please send her a brief email of your
hopes and feelings about getting this approved. :)

Food and Drug Administration to Hold Hearing on BENLYSTA®

On November 16, 2010, the Food and Drug Administration (FDA) will hold a hearing to discuss the application to approve BENLYSTA® (belimumab) as a
treatment to reduce disease activity adults with active, autoantibody-positive lupus.

If approved, BENLYSTA® will be the first drug to be specifically developed
for lupus and the first new treatment for lupus in more than 50 years.

While BENLYSTA® may not be appropriate for all people with lupus, having a
new approved treatment for lupus would be a significant step forward and
would provide a pathway for future approval of the arsenal of therapies
required to manage a disease as diverse and complex as lupus.

Make your voice heard! It is important for the FDA Committee to have a clear
understanding of the diversity of the disease and how it impacts people
with lupus and their families. You can help by sharing your story about
why new treatments are needed and the hope for new treatments in the

Email your short statement to Yvette Waples at the FDA, by November 1, 2010.

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