LymeNet Flash: Tafenoquine gets U.S. Food and Drug Administration

LymeNet on Facebook

LymeNet on Twitter

Follow @LymeDiseaseNet

The Lyme Disease Network receives a commission from Amazon.com for each purchase originating from this site.

When purchasing from Amazon.com, please
click here first.

Thank you.

Dedicated to the Bachmann Family

LymeNet needs your help:
LymeNet 2020 fund drive

The Lyme Disease Network is a non-profit organization funded by individual donations.

»	LymeNet Flash » Questions and Discussion » Medical Questions » Tafenoquine gets U.S. Food and Drug Administration

UBBFriend: Email this page to someone!

Author

Topic: Tafenoquine gets U.S. Food and Drug Administration

Pocono Lyme
Frequent Contributor (1K+ posts)
Member # 5939

posted

Tafenoquine gets U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation News
Tafenoquine gets U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation
GlaxoSmithKline (GSK) and Medicines for Malaria Venture (MMV) announced on December 20, 2013 that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for tafenoquine.

Tafenoquine is an investigational 8-aminoquinoline derivative for the treatment and relapse prevention of Plasmodium vivax malaria. It is not yet approved or licensed for use anywhere in the world.

Breakthrough Therapy designation is a new FDA programme aimed at accelerating the development and review times of drugs for serious or life-threatening conditions like malaria.

The Breakthrough Therapy designation was granted based on the results from an international, multicentre, randomised Phase II clinical trial in more than 300 patients with uncomplicated P. vivax malaria. The detailed results were published online in The Lancet in December 2013.

More information about the FDA Breakthrough Therapy program is available here:
http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm

More information about the results of the Phase II clinical trial on tafenoquine published in The Lancet is available here: http://www.sciencedirect.com/science/article/pii/S0140673613625684. The article will be freely available on Malaria Nexus soon.

--------------------
2 Corinthians 12:9-11

9 But he said to me, �My grace is sufficient for you, for my power is made perfect in weakness.� Therefore I will boast all the more gladly about my weaknesses, so that Christ�s power may rest on me.

Posts: 1445 | From Poconos, PA | Registered: Jul 2004 | IP: Logged |

seibertneurolyme
Frequent Contributor (5K+ posts)
Member # 6416

posted

Great news -- maybe finally a new a med for babesia.

Bea Seibert

Posts: 7306 | From Martinsville,VA,USA | Registered: Oct 2004 | IP: Logged |

Printer-friendly view of this topic

The Lyme Disease Network is a non-profit organization funded by individual donations. If you would like to support the Network and the LymeNet system of Web services, please send your donations to:

The Lyme Disease Network of New Jersey
907 Pebble Creek Court, Pennington, NJ 08534 USA
http://www.lymenet.org/