Generic version of abacavir approved for use by PEPFAR programmes

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The US Food and Drug Administration (FDA) has announced tentative approval for a generic version of abacavir tablets (300 mg), manufactured in India by Aurobindo Pharma. Abacavir sulfate tablets are the first generic version of the already approved Ziagen, an anti-HIV medication manufactured by GlaxoSmithKline. Tentative approval makes this product available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).

The agency's tentative approval means that Aurobindo's product meets all of FDA's manufacturing quality and clinical safety and efficacy standards, but existing patents and/or exclusivity prevent its marketing in the United States at this time.

Earlier this year the Clinton Foundation announced that it had secured an agreement with the Indian generic manufacturer Cipla to offer a generic version of abacavir at a ceiling price of $440 a year. It is unclear whether Aurobindo will also participate in this agreement.

Glossary

generic

In relation to medicines, a drug manufactured and sold without a brand name, in situations where the original manufacturer’s patent has expired or is not enforced. Generic drugs contain the same active ingredients as branded drugs, and have comparable strength, safety, efficacy and quality.

nucleoside

A precursor to a building block of DNA or RNA. Nucleosides must be chemically changed into nucleotides before they can be used to make DNA or RNA. 

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

drug interaction

A risky combination of drugs, when drug A interferes with the functioning of drug B. Blood levels of the drug may be lowered or raised, potentially interfering with effectiveness or making side-effects worse. Also known as a drug-drug interaction.

reverse transcriptase

A retroviral enzyme which converts genetic material from RNA into DNA, an essential step in the lifecycle of HIV. Several classes of anti-HIV drugs interfere with this stage of HIV’s life cycle: nucleoside reverse transcriptase inhibitors and nucleotide reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs). 

Abacavir is a nucleoside reverse transcriptase inhibitor (NRTI), and is a useful alternative to zidovudine (AZT) or stavudine (d4T), nucleoside analogues that may cause side effects such as anaemia and lactic acidosis respectively. However, even at a reduced price of $440 a year it is unlikely to be widely adopted as an alternative nucleoside analogue in developing countries.

Abacavir’s main use is likely to be in patients with tuberculosis who require immediate antiretroviral therapy alongside rifampicin, since it does not interact with rifampicin unlike the non-nucleoside nevirapine and the protease inhibitors.