KUALA LUMPUR: The health ministry has granted a conditional registration approval for Veklury (remdesivir) for the emergency treatment of Covid-19.
Health director-general Dr Noor Hisham Abdullah said the treatment was agreed and approved at the 374th Drug Control Authority (DCA) meeting 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 quality, safety and effectiveness of antivirus products will be monitored and evaluated continuously by the National Pharmaceutical Regulatory Agency (NPRA) based on the latest data.
“This is to ensure that the benefit-over-risk comparison for the product remains positive,” he said in a statement.
Noor Hisham said the ministry remained committed to improving the public’s access to medicines for the purpose of treatment or prevention of Covid-19 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 40kg with positive viral test results, hospitalised, or not hospitalised and have mild-to-moderate Covid-19 and are at high risk for it to get worse.
In a separate statement, Noor Hisham said the DCA also approved the conditional registration of a new fixed-dose combination product for HIV-1 treatment called 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, and registered under Camber Laboratories Sdn Bhd 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. - FMT
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