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[e-drug] FDA Breakthrough Therapy designation for tafenoquine for Plasmodium vivax malaria

E-DRUG: FDA Breakthrough Therapy designation for tafenoquine for Plasmodium 
vivax malaria
-----------------------------------------------------------------------------------------------------

Dear colleagues,

We have some exciting news to share just before the holidays: the US Food and 
Drug Administration has just granted Breakthrough Therapy designation for 
tafenoquine, an investigational medicine for the treatment and relapse 
prevention of Plasmodium vivax malaria. The designation will expedite the 
regulatory review process of the potential new medicine, which has just 
successfully completed Phase II clinical trials.

Please find the press release and supporting information copied below and 
attached as a pdf to this message.

Don't hesitate to contact me should you have any questions.
Best wishes,
Lizzie

Issued: 3.30 pm GMT 20 December 2013, London UK & Geneva Switzerland

MMV and GSK announce FDA Breakthrough Therapy designation for tafenoquine for 
Plasmodium vivax malaria

Medicines for Malaria Venture (MMV) and GlaxoSmithKline (GSK) announced today 
that the U.S. Food and Drug Administration (FDA) has granted Breakthrough 
Therapy designation for tafenoquine, an investigational medicine for the 
treatment and relapse prevention of Plasmodium vivax malaria.  Tafenoquine is 
not yet approved or licensed for use anywhere in the world. Breakthrough 
Therapy designation is the newest of the FDA's programmes aimed at accelerating 
the development and review times of drugs for serious or life-threatening 
conditions.

P. vivax malaria is a neglected tropical disease and a major cause of 
uncomplicated malaria. It has a significant public health and economic impact 
primarily in South and South East Asia, Latin America and the horn of Africa, 
where the majority of the estimated 70-390 million annual clinical cases occur. 
The P. vivax parasite causes relapses from a dormant liver form established 
immediately after an infected mosquito bite. This dormant form leads to the 
reappearance of clinical malaria anywhere between a few weeks and several 
months after the initial infection. There is a need to provide alternative 
treatments to manage P. vivax relapse with shorter treatment regimens.

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. Headline results from this trial 
were presented at the American Society of Tropical Medicine and Hygiene Meeting 
in November 2013, and detailed results published in The Lancet in December 
2013. Plans are underway to start a Phase III study in 2014.

About Breakthrough Therapy Designation
The Breakthrough Therapy designation was enacted as part of the 2012 FDA Safety 
and Innovation Act (FDASIA). The goal is to expedite the development and 
regulatory review of designated drugs to treat serious or life-threatening 
medical conditions when the drug may have substantial improvement over 
available therapies. Breakthrough Therapy designation includes all the features 
of the Fast Track designation, as well as more intensive guidance from the FDA 
on a drug's clinical development programme.

About Tafenoquine
Tafenoquine is an investigational 8-aminoquinoline derivative with activity 
against the P. vivax lifecycle, including the form that lies dormant in the 
liver causing relapse of infection weeks to months following the initial 
mosquito bite. Tafenoquine was first discovered by scientists at the Walter 
Reed Army Institute of Research in 1978 and is being developed in collaboration 
between GSK and MMV. Tafenoquine is being administered as a single dose during 
clinical trials in patients with P. vivax malaria.

Medicines for Malaria Venture (MMV)
MMV is a leading product development partnership (PDP) in the field of 
antimalarial drug research and development working towards the vision of a 
malaria-free world. Its 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. Since its foundation in 
1999, MMV has developed and brought to registration four new medicines with 
partners from over 300 pharmaceutical, academic and endemic-country partners in 
50 countries. With its partners MMV manages the largest portfolio of 
antimalarial R&D projects ever assembled, encompassing over 65 projects.

MMV is grateful to its donors, including the Bill and Melinda Gates Foundation, 
the governments of Australia, Ireland, Switzerland, the United Kingdom and the 
United States of America, as well as the Wellcome Trust, the ExxonMobil 
Foundation and Newcrest Mining Ltd, whose support make this vital work possible.

Elizabeth Poll | Medicines for Malaria Venture
Editor and Publications Officer
T: +41 22 799 45 81 | M: +41 79 907 59 92
Email: polle@mmv.org

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