KUALA LUMPUR, July 7 — The Health Ministry (MOH) has granted a conditional registration approval for Veklury (remdesivir) for the emergency treatment of COVID-19.
Health director-general Tan Sri Dr Noor Hisham Abdullah said the treatment was agreed and approved at the 374th Drug Control Authority (DCA) meeting which convened today.
However, he said the product was not intended to be used to replace COVID-19 vaccines or public health measures, especially regarding compliance with standard operating procedures (SOPs).
“The MOH wishes to inform that this conditional registration approval requires that information on the quality, safety and effectiveness of antivirus products be monitored and evaluated continuously by the National Pharmaceutical Regulatory Division (NPRA) based on the latest data from time to time.
“This is to ensure that the benefit over risk comparison for the product remains positive,” he said in a statement here today.
Dr Noor Hisham said the MOH remained committed to improving the people’s access to medicines for the purpose of treatment or prevention of COVID-19 transmission in Malaysia by ensuring that they were properly evaluated based on quality, safety and effectiveness.
Veklury is indicated for COVID-19 treatment in adults and pediatric patients, aged 12 and older and weighing at least 40 kilogrammes (kg) with positive SARS-CoV-2 viral test results, hospitalised, or not hospitalised and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19 including hospitalisation or death.
In a separate statement, Dr Noor Hisham said the DCA also approved the conditional registration of a new fixed-dose combination product for HIV-1 treatment, namely TELDY Film-Coated Tablets (TELDY).
He said TELDY contained a combination of three active ingredients involving dolutegravir 50 milligrammes (mg), lamivudine (300mg) and tenofovir disoproxil fumarate (300mg), adding that the product is manufactured by Hetero Labs Limited, India while Camber Laboratories Sdn Bhd is its registration holder in Malaysia.
The NPRA evaluation on the quality, safety and efficacy data of TELDY products was found to be satisfactory for use on its own as a complete regimen for the treatment of HIV-1 infection among adults and adolescents aged 12 years and above who weigh 40 kg or more,” he said.
He said TELDY, the first dolutegravir-based combination product registered in the country was a benefit from the Voluntary Licensing (VL) agreement between Medicines Patent Pool (MPP) and dolutegravir patent owner ViiV Healthcare.
He said the VL agreement enables HIV patients’ access to dolutegravir-based products to be enhanced in line with World Health Organisation’s (WHO) recommendation on the use of the substance as the primary treatment for HIV patients.
“MOH through NPRA will continue to monitor and evaluate the latest data on the quality, safety and effectiveness of TELDY products, from time to time, to ensure that the benefit-risk balance remains positive,” said Dr Noor Hisham.