Malaysia registers HIV combination therapy

KUALA LUMPUR, July 7 – The National Drug Regulatory Agency (NPRA) today issued conditional approval for an oral combination drug as the current standard of treatment for HIV.

Director General of Health Dr Noor Hisham Abdullah said the NPRA had authorized the use of TELDY film-coated tablets – which is a combination of dolutegravir, lamivudine and tenofovir disoproxil fumarate – as the only complete regimen to treat HIV infection in adults and adolescents aged 12 years and older people who weigh 40 kg or more.

“TELDY is the first dolutegravir-based combination therapy registered in this country and is the result of a Voluntary License (VL) agreement between the Medicines Patent Pool (MPP) and dolutegravir’s patent owner, ViiV Healthcare,” said said Dr Noor Hisham in a statement today.

He said the MPP, which is a United Nations-backed public health organization that seeks to increase access to lifesaving medicines in low- and middle-income countries, has extended voluntary licenses to three manufacturers, including Hetero Labs. Limited in India, to produce the HIV drug for the Malaysian market.

Viiv Healthcare is a pharmaceutical company specializing in HIV medicines, headquartered in the United Kingdom.

The Malaysian Medicines Control Authority (DCA) previously granted conditional approval for Tegrad tablets, which contain dolutegravir as the sole active ingredient, under the same product registration holder, Camber Laboratories Sdn Bhd, and the manufacturer Hetero Labs Limited on February 10.

DG Health estimated 92,063 HIV patients among adults and children in Malaysia in 2020.

“Therefore, this CV agreement will increase HIV patients’ access to dolutegravir products, in line with the World Health Organization (WHO) recommendation for dolutegravir as first-line treatment for HIV-positive patients. “

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