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FDA gives preliminary OK to drug aimed at Duchenne muscular dystrophy

September 19, 2016 3:07 PM

Today, the Food and Drug Administration preliminarily approved eteplirsen, making the drug available to other Duchenne sufferers who have been waiting for years as the FDA missed decision deadlines and required more and more data from manufacturer Sarepta Therapeutics in Massachusetts.

The action makes eteplirsen the first drug approved to treat muscular dystrophy.

Approval came under an accelerated process for “orphan drugs” prescribed for rare diseases for which there are no other treatments. Because the drug was fast tracked, confirmatory studies are required before it can be given full approval.

Full story here:

http://www.post-gazette.com/business/healthcare-business/2016/09/19/FDA-gives-preliminary-OK-to-drug-aimed-at-Duchenne-muscular-dystrophy/stories/201609190182


This Announcements page's purpose is to post any new or timely data, such as meeting dates - or cancellations.

D.A.H.R.T.

Disabled Americans Have Rights Too

Our Annual Christmas Party for disabled kids is December 8 this year. We usually have about 50 'partygoers'. At our Dec. 1 meeting, we will be wrapping gifts for the kids and decorating the place. See you then?

Our next meeting is Saturday, 1 December, and will be held at our office in the Northwest Paralyzed Veterans of America building, 616 SW 152nd in Burien.  Ph 206-241-1697 for further information.

Be certain to confirm ahead of time in the event of changes,