E-DRUG: FDA Breakthrough Therapy designation for tafenoquine for Plasmodium
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.
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
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.
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