FDA approves high priority drug 5 months early | PVCT Message Board Posts

Provectus Biopharmaceuticals, Inc.

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Msg  51278 of 51573  at  10/21/2019 6:27:04 PM  by

agrossfarm


FDA approves high priority drug 5 months early

said acting FDA Commissioner Ned Sharpless, M.D.

“That’s why we used all available programs, including Priority Review, Fast Track, Breakthrough Therapy, and orphan drug designation, to help advance today’s approval in the most efficient manner possible, while also adhering to our high standards. The FDA remains committed to advancing novel treatment options for areas of unmet patient need....”

https://www.fda.gov/news-events/press-announcements/fda-approves-new-breakthrough-therapy-cystic-fibrosis

"The U.S. Food and Drug Administration today approved Trikafta (elexacaftor/ivacaftor/tezacaftor), the first triple combination therapy available to treat patients with the most common cystic fibrosis mutation. Trikafta is approved for patients 12 years and older with cystic fibrosis who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which is estimated to represent 90% of the cystic fibrosis population."


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