[il s'agit du Pyramax qui est composé de pyronaridine et d'artesunate. Pas de traduction disponible pour l'instant.CB]
European Medicines Agency recommends new anti-malaria treatment for use
outside the European Union
Press release
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/
02/news_detail_001449.jsp&mid=WC0b01ac058004d5c1
17/02/2012
European Medicines Agency recommends new anti-malaria treatment for use
outside the European Union
European Medicines Agency's opinion intended to support countries outside
the European Union to get new treatment option to market to fight World
Health Organization target disease
The European Medicines Agency has recommended Pyramax, a fixed combination
consisting of pyronaridine and artesunate, an artemisinin derivative, from
Shin Poong Pharmaceutical Co. Ltd, for the treatment of acute, uncomplicated
malaria infection caused by Plasmodium falciparum or by Plasmodium vivax in
adults and children weighing 20 kg or more, in areas of low transmission
with evidence of artemisinin resistance.
The scientific opinion for Pyramax was given under Article 58 of Regulation
(EC) No 726/2004, which allows the Agencys Committee for Medicinal Products
for Human Use (CHMP) to give a scientific opinion, in cooperation with the
World Health Organization (WHO), on medicines for human use intended
exclusively for markets outside the European Union (EU). Applicants can use
the CHMPs scientific opinion as a basis when applying for a marketing
authorisation in countries outside of the EU. The scientific opinion also
facilitates the WHO prequalification process.
Medicines eligible for this procedure are used to prevent or treat diseases
of major public health interest, including vaccines used in the WHO Expanded
Programme on Immunisation or for protection against a public health priority
disease, as well as medicines for WHO target diseases such as HIV/AIDS,
malaria or tuberculosis.
The application for Pyramax was evaluated by the CHMP with participation of
WHO experts and experts and observers from medicines agencies from countries
outside the EU. The Committee concluded that the efficacy of Pyramax was
demonstrated. However, due to concerns about severe liver problems
associated with repeated use, Pyramax should only be used as single 3-day
treatment course, in areas of low transmission with evidence of decreased
efficacy of other oral artemisinin-based combination therapies, consistent
with WHO recommendations. Pyramax should only be used at controlled sites
where a patients liver function can be systematically monitored and where
exhaustive collection of adverse events as well as reliable information on
resistance can be ensured.
The development program for Pyramax was a joint development program between
Shin-Poong Pharmaceuticals and Medicines for Malaria Venture, a
not-for-profit foundation dedicated to drug development of treatments for
malaria. The clinical trials were conducted in Africa and Asia in adults and
in children weighing 20 kg or more.
The applicant has agreed to further investigate possible mechanisms of liver
toxicity and to perform repeated dosing studies to determine the full scope
of liver toxicity of Pyramax and the safety of repeated treatment courses in
endemic areas. These data will allow the CHMP to consider whether the
current recommendations can be altered.
Malaria is a life-threatening disease caused by parasites that are
transmitted to people through the bites of infected mosquitoes, and affects
mainly young children and pregnant women. The WHO estimates that in 2010,
there were 216 million cases of malaria with some 655 000 deaths.
Approximately half of the world's population is at risk of malaria. Most
malaria cases and deaths occur in sub-Saharan Africa. However, Asia, Latin
America and to a lesser extent the Middle East and parts of Europe are also
affected. In 2010, malaria was present in 106 countries and territories.
P. falciparum, the parasite causing the most lethal type of human malaria,
has become resistant to many conventional treatments in most parts of the
world. Artemisinin derivatives, including artesunate, are widely used
anti-malarial drugs, clearing parasites rapidly. Resistant strains of P.
falciparum might develop if artemisinin derivatives are used alone. In order
to prevent the occurrence of drug resistance to artemisinins and to address
the issue of its relatively short half-life, artemisinins are recommended by
the WHO to be given in combination with another anti-malarial agent with a
longer half-life. In the case of Pyramax the artemisin derivative has been
combined with pyronaridine.
In January 2011, the WHO released the Global Plan for Artemisinin Resistance
Containment to deal with the threat of artemisinin resistance, with the
objective of protecting artemisinin-based combination therapies as an
effective treatment for P. falciparum malaria by defining priorities for the
containment and prevention of artemisinin resistance.
Note
* The scientific assessment of the CHMP will be published within 2 to
3 months after adoption of the scientific opinion as part of the European
public assessment report on a scientific opinion in cooperation with WHO and
will be available on the Agencys website.
Name Language First published Last updated
European Medicines Agency recommends new anti-malaria treatment for use
outside the European Union
<http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012
/02/news_detail_001449.jsp&mid=WC0b01ac058004d5c1#> (English only)
17/02/2012