PUTRAJAYA, Feb 8 — The company that has been granted conditional registration approval for Lagevrio for the treatment of Covid-19 must submit the latest safety data from time to time through rolling submission to the National Pharmaceutical Regulatory Agency (NPRA), said its director Rosilawati Ahmad.
She said the Drug Control Authority (DCA) had in April last year granted conditional registration approval for use during disaster on Lagevrio (active ingredient Molnupiravir) to the registration holder company Merck Sharp & Dohme (Malaysia) Sdn Bhd and manufacturers Patheon Inc (Canada), Patheon Pharmaceuticals Inc (United States) and MSD International GmbH (Puerto Rico Branch) LLC (Puerto Rico).
The product is used to treat adult patients with mild to moderate Covid-19 caused by SARS-CoV-2. Lagevrio acts on the Covid-19 virus by introducing errors in the viral genome leading to inhibition of replication.
Rosilawati in a statement today said that a review on the quality and safety data of the product submitted by the company during product registration found no information on the emergence of new harmful virus variants.
“As this product has been granted conditional registration approval, the companies must submit the latest safety data to NPRA from time to time through rolling submission,” she said.
Rosilawati was commenting on an article published by Bloomberg and Science, which claimed that the drug Lagevrio for the treatment of Covid-19 is likely to cause the production of new viral mutations in patients, which are easily spread and could pose serious and long-term health risks.
The product manufacturer, Merck Sharp & Dohme, in denying the claims stated there has been no evidence to show that the Lagevrio drug caused the emergence of new variants.
She said all registered medicinal products in Malaysia have gone through a rigorous evaluation process in terms of efficacy, safety and quality before being approved by the DCA.
“Only products that are effective, safe and of quality based on evidence and clear clinical research will be approved by the DCA,” Rosilawati said.
She added the Ministry of Health through the NPRA always ensures that all pharmaceutical products supplied in Malaysia are evaluated in all aspects of quality, safety and effectiveness.
“The benefit-risk assessment of drugs for Covid-19 treatment that are granted conditional registration approval are being carried out continuously based on the latest data submitted from time to time,” Rosilawati said.
— Bernama
