KUALA LUMPUR, July 7 – The National Pharmaceutical Regulatory Agency (NPRA) today issued conditional approval for an oral combination medication as the current standard of care treatment for HIV.
Health director-general Dr Noor Hisham Abdullah said the NPRA authorised use of TELDY film-coated tablets – which is combination of dolutegravir, lamivudine, and tenofovir disoproxil fumarate – as a sole complete regimen to treat HIV infection among adults and adolescents aged 12 years and older who weigh 40kg or more.
“TELDY is the first dolutegravir-based combination treatment registered in this country and was the result of a voluntary licensing (VL) agreement between the Medicines Patent Pool (MPP) and the dolutegravir patent owner, ViiV Healthcare,” Dr Noor Hisham said in a statement today.
He said the MPP, which is a United Nations-backed public health organisation that seeks to increase access to lifesaving medicines in low- and middle-income countries, has extended voluntary licences to three manufacturers, including Hetero Labs Limited in India, to produce the HIV drug for the Malaysian market.
Viiv Healthcare is a specialist pharmaceutical company dedicated to HIV medicines, with its corporate headquarters located in the UK.
Malaysia’s Drug Control Authority (DCA) previously gave conditional approval for Tegrad tablets, which contain dolutegravir as the sole active ingredient, under the same product registration holder, Camber Laboratories Sdn Bhd, and manufacturer Hetero Labs Limited last February 10.
The Health DG estimated 92,063 HIV patients among adults and children in Malaysia in 2020.
“Therefore, this VL agreement will increase HIV patients’ access to dolutegravir-based products, in line with the World Health Organization’s (WHO) recommendation for dolutegravir as the first-line treatment for HIV patients.”