Dr Noor Hisham: Ministry of Health grants conditional approval to Veklury for treatment of Covid-19
Veklury is indicated for the treatment of Covid-19 in adults and pediatric patients, aged 12 years and over and weighing at least 40 kg with positive SARS-CoV-2 viral test results, hospitalized or non-hospitalized and having a mild to moderate Covid-19 and are at high risk of progression to severe Covid-19, including hospitalization or death. — Photo by Ahmad Zamzahuri
Thursday July 07, 2022 21:45 MYT
KUALA LUMPUR, July 7 – The Ministry of Health (MOH) has granted conditional registration approval for Veklury (remdesivir) for the emergency treatment of Covid-19.
Chief Health Officer Tan Sri Dr Noor Hisham Abdullah said the treatment was agreed and approved at the 374th meeting of the Medicines Control Authority (DCA) held today .
However, he said the product was not intended to be used as a replacement for Covid-19 vaccines or public health measures, especially with respect to following standard operating procedures (SOPs).
“The Department of Health wishes to inform that this conditional registration approval requires that information on the quality, safety and effectiveness of anti-virus products be continuously monitored and evaluated by the National Division of Drug Regulation (NPRA) on the basis of the latest data from time to time.
“This is to ensure that the comparison of benefits versus risks for the product remains positive,” he said in a statement today.
Dr Noor Hisham said the Ministry of Health remained committed to improving people’s access to medicines for the purpose of treating or preventing the transmission of Covid-19 in Malaysia by ensuring that they are properly evaluated for quality, safety and efficacy.
Veklury is indicated for the treatment of Covid-19 in adults and pediatric patients, 12 years of age and older and weighing at least 40 kilograms (kg) with positive SARS-CoV-2 viral test results, hospitalized or non-hospitalized and presenting with Covid-19 and are at high risk of progression to a severe form of Covid-19, including hospitalization or death.
In a separate statement, Dr. Noor Hisham said the DCA has also approved the conditional registration of a new fixed-dose combination product for the treatment of HIV-1, namely TELDY film-coated tablets (TELDY).
He said TELDY contains a combination of three active ingredients involving dolutegravir 50 milligrams (mg), lamivudine (300 mg) and tenofovir disoproxil fumarate (300 mg), adding that the product is manufactured by Hetero Labs Limited, in India, while Camber Laboratories Sdn Bhd is its registration. holder in Malaysia.
The NPRA’s evaluation of the quality, safety and efficacy data for TELDY products has been found satisfactory for use as a comprehensive treatment for HIV-1 infection in adults and older adolescents. 12 years and older who weigh 40 kg or more,” he said.
He said TELDY, the first dolutegravir combination product registered in the country, was a benefit of the Voluntary License (VL) agreement between the Medicines Patent Pool (MPP) and dolutegravir patent owner ViiV Healthcare.
He said the CV agreement improves access for HIV-positive patients to dolutegravir products in line with the World Health Organization (WHO) recommendation on the use of the substance as main treatment. for HIV-positive patients.
“The Department of Health through the NPRA will continue to monitor and evaluate the latest data on the quality, safety and efficacy of TELDY products from time to time to ensure that the benefit report /risk remains positive,” said Dr Noor Hisham. — Bernama