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[e-drug] WHO prequalifies ARV FDCs

E-DRUG: WHO prequalifies ARV FDCs
[WHO recently prequalified new 3-in-1 fixed dose combinations for HIV/AIDS.
Cipla's and ranbaxy's 3-in-1 combinations Lamivudine / Stavudine /
Nevirapine are now prequalified.

Until recently, GSK's Lamivudine+Zidovudine+ Abacavir was the only 3-in-1
ARV FDC on the WHO prequalification list, but this is expensive, and recent
studies have shown that abacavir is not as good as it originally looked.

The 11th edition of the prequalification project is available at:

E-drug did not yet report on this important step - apologies. Below the WHO
press relase. WB]


WHO adds new fixed dose combinations to its list of quality products for
AIDS treatment
Key component of 3 by 5 strategy

1 December 2003 | GENEVA -- As the World Health Organization (WHO) and
UNAIDS today launch their 3 by 5 strategy to treat three million people
living with AIDS by 2005, there is already substantial progress in one key
area. WHO is adding three new generic products for first-line AIDS treatment
to its list of medicines meeting WHO standards of quality, safety and

The products are fixed-dose triple therapy combinations containing
lamivudine, stavudine and nevirapine. Their introduction in the list of
quality medicines will increase choice and competition, thus contributing to
make AIDS treatment progressively more affordable.

?The 3 by 5 strategy recommends simplified AIDS treatment regimens so that
countries can quickly expand access to antiretroviral medicines," said Dr
Vladimir Lepakhin, WHO Assistant Director-General for Health Technology and
Pharmaceuticals. ?These new products will help the countries which are
hardest-hit by the AIDS epidemic get easy-to-take AIDS medicines to the
people who need them most urgently." Single-pill combinations of
antiretrovirals are a major breakthrough for AIDS treatment in poor
countries as they improve the reliability and security of supplies, which
has so far been one of the major obstacles to access. From a therapeutic
point of view, they reduce the number of pills, are easier to take and
promote greater patient compliance. They also ensure that the right dosage
of each substance is given to the patient.

As part of the 3 by 5 strategy, WHO and its partners have set up the AIDS
Medicines and Diagnostics Service (AMDS), a new mechanism created to make
sure that the supply of safe, effective and affordable medicines of good
quality are more easily accessible.

The WHO Prequalification Project will work with the AMDS to assess the
quality, safety and clinical efficacy of HIV medicines distributed in
developing and transition countries. At present, the Prequalification list
contains over 50 single-drug, two-drug, and three-drug combinations,
including the three newly qualified products. In assessing products and
their manufacturers, Prequalification provides a rigorous review process and
ongoing quality monitoring. One of the benefits of this initiative is that
it limits the entry of substandard and counterfeit medicines into the supply
channels. In addition, the project helps build local regulatory and
production capacity by involving local experts in the evaluations.
Prequalification also respects intellectual property rights while reflecting
the highest public health standards.

The project, which partners with UNICEF, UNAIDS, the UN Population Fund
(UNFPA) and receives support from the World Bank, has been running for two
years. It will keep adding products and suppliers to its list, as and when
they are found to meet the set standards.

?We are involved in a dynamic process,? explains Jonathan Quick, Director of
Essential Drugs and Medicines Policy at WHO. ?We expect that the list will
grow steadily as more companies take an interest in participating and
countries expand their HIV/AIDS programmes.?

For more information contact:

Iain Simpson
Telephone: +41 22 791 3215
Email: simpsoni@who.int

Daniela Bagozzi
Telephone: +41 22 791 4544
Email: bagozzid@who.int

Samantha Bolton
Telephone: +41 22 791 1970
Email: boltons@who.int

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