E-DRUG: EMA approval procedures and recent approvals of two new
antimalarials
---------------------------------------------------------------
Until I saw the recent approval by EMA of the new fixed-dose antimalarial
Pyramax, I was not aware of the new cooperation between the European
Medicines Agency (EMA) and the WHO prequalification project. You can read
about it here:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general
_content_000312.jsp&mid=WC0b01ac058001d12c&jsenabled=true [repair link if
broken]
This cooperation means EMA may approve medicines, incl. vaccines, eligible
for use to prevent or treat diseases of major public health interest. EMA
says: this includes vaccines used in the WHO Expanded Programme on
Immunisation or for protection against a public priority disease, as well as medicines for WHO target diseases such as HIV/AIDS, malaria, or
tuberculosis.
As per 1 February 2012, EMA lists the following products as having been
approved with this condition:
Aluvia (lopinavir/ritonavir)
Lamivudine ViiV (lamivudine)
Lamivudine/Zidovudine ViiV (lamivudine/zidovudine)
GSK has withdrawn its application for the vaccine Globorix
(DPT+HepB+H.influenzaeB+N.meningitidisA+C)
In February 2012 a new fixed dose antimalarial, Pyramax (pyroaridine and
artesunate) was approved on this condition. You can read more about Pyramax
here:
Press release:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/
02/news_detail_001449.jsp&mid=WC0b01ac058004d5c1 [repair link if broken]
Product information:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/
02/news_detail_001449.jsp&mid=WC0b01ac058004d5c1 [repair link if broken]
In November 2011 the fixed dose combination Eurartesim (piperaquine and
dihydroartemisinin) was approved without this condition and can therefore
also be sold in Europe:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/
001199/human_med_001450.jsp&mid=WC0b01ac058001d124 [repair link if broken]
This email has three messages:
1) inform you about the EMA/WHO cooperation to speed up approval of quality
medicines for important diseases intended for markets outside the European
Union.
2) inform about the recent approval of two new fixed dose antimalarials.
3) inform that one of these two antimalarials has been approved under the
normal EU procedure (Eurartesim) and one under the conditional procedure
(Pyramax).
If E-druggers feel this illustrates double standards or have other comments, your comment will be welcome!
Kirsten Myhr, MScPharm, MPH
Special advisor
RELIS Medicines Information & Pharmacovigilance Centre
Oslo University Hospital
private: myhr[at]online.no
work: kirsten.myhr[at]ous-hf.no