KUALA LUMPUR: The Health Ministry 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 (SOP).
“The ministry 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 Thursday (July 7).
Dr Noor Hisham said the ministry 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.
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 50mg, 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 40kg 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.
“The ministry 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. – Bernama