Contributed by Ron Gara| 25 January, 2005 20:03 GMT
Many of the most vulnerable victims of HIV/AIDS in Africa soon may have access to life-saving treatments at a far cheaper cost following the announcement Tuesday by the U.S. Food and Drug Administration (FDA) of its tentative approval of a co-packaged antiretroviral drug regimen manufactured by Aspen Pharmacare of South Africa.The agency's tentative approval means that although existing patents and/or
exclusivity prevent U.S. marketing of Aspen's product, it meets FDA's quality,
safety and efficacy standards for U.S. marketing. This action makes this product
available for potential procurement by President Bush's Emergency
Plan for AIDS Relief.
Expedited Review Process
Tuesday's action is the first tentative approval of an HIV drug regimen
manufactured by a non-U.S.-based generic pharmaceutical company. Once Aspen 's
marketing application was complete on January 13, 2005, FDA completed its review
within two weeks.
"Through an expedited review process, FDA has worked diligently to approve a
product with great public health significance. Our contributions to the goals of
the emergency plan are an integral part of that effort," said Dr. Lester M.
Crawford, Acting FDA Commissioner.
'Poorest, Most Vulnerable, Most Desperate'
"This announcement enables Aspen to manufacture cost-effective generic ARVs
for society's poorest, most vulnerable and most desperate and who have been
afflicted by the biggest medical scourge we have seen in recent times," says
Stephen Saad, Aspen Pharmacare Group Chief Executive. "It is with pride that
Aspen, a South African company, is at the forefront of the battle against
HIV/Aids," he added.
The Emergency Plan for AIDS Relief, which President Bush first announced in
his 2003 State of the Union Address, is currently providing $15 billion to fight
the HIV/AIDS pandemic over five years, with a special focus on 15 of the hardest
hit countries. It targets three specific areas related to HIV/AIDS:
- Prevention of HIV transmission;
- Treatment of AIDS and associated conditions;
- Care, including palliative care for HIV infected-individuals, and care for
orphans and vulnerable children.
Most Widely Used Triple Cocktail Regimen
The tentatively approved regimen consists of co-packaged
lamivudine/zidovudine fixed dose combination tablets and nevirapine tablets.
This treatment is the world's most widely used triple cocktail antiretroviral
regimen, according to Aspen Pharmacare.
Lamivudine/zidovudine fixed dose combination tablets are a version of the
already approved Combivir tablets manufactured by GlaxoSmithKline, and
nevirapine tablets are a version of Viramune tablets manufactured by
Boehringer-Ingelheim.
The new co-packaged product consists of two tablets (lamivudine/zidovudine
and nevirapine) each to be taken twice daily, after the initial two-week
initiation phase of this nevirapine regimen.
More information on HIV and AIDS is available at FDA's website.
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