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FDA Breakthrough Therapy Designation: 28 And Counting

December 20, 2013

On December 20, GlaxoSmithKline (GSK) and Medicines for Malaria Venture (MMV), announce that the FDA grants a Breakthrough Therapy Designation (BTD) for Tafenoquine, an investigational medicine for the treatment and relapse prevention of Plasmodium vivax malaria. This is the 28th BTD that is announced by a sponsor company – GSK and MMV. This is the 3rd FDA BTD that GSK receives in 2013:

Row Num

Drug Name

Sponsor                     Company Indication


Drisapersen GlaxoSmithKline Duchenne   Muscular



Ofatumumab Genmab/GSK Chronic   Lymphocytic

Leukemia   (CLL)


Tafenoquine GSK/Medicines for Malaria Venture Plasmodium Vivax   Malaria


Plasmodium vivax malaria is a “neglected” tropical disease and a major cause of uncomplicated malaria. It is prevalent in Latin America, Southeast Asia, and the horn of Africa, where the majority of the approximately 70-390 million annual clinical cases exist. Plasmodium vivax malaria of all the types of malaria is “the most elusive to cure.”

The BTD is granted based on results from an international, multicenter, randomized, dose-ranging Phase II clinical trial in more than 300 patients with uncomplicated Plasmodium vivax malaria. The clinical trial studies Tafenoquine + 3 days of Chloroquine for the treatment of Plasmodium vivax malaria (relapsing). These clinical trial results are published online December 19th, in the journal The Lancet :

Llanos-Cuentas A et al. Tafenoquine plus chloroquine for the treatment and relapse prevention of Plasmodium vivax malaria (DETECTIVE): a multicenter, double-blind, randomized, phase II dose-selection studyThe Lancet (2013). doi:10.1016/S0140-6736(13)62568-4.

MMV is a not-for-profit public-private partnership that is founded as a foundation in Switzerland in 1999. The mission :

“is to reduce the burden of malaria in disease-endemic countries by discovering, developing, and facilitating delivery of new, effective and affordable antimalarial drugs.”

Please Note: FDA Official Logo from FDA website.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.


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