PETALING JAYA: The Medicines Control Authority of the Ministry of Health has granted conditional registration of the Ravida 200 mg tablet, composed of ravidasvir hydrochloride, to treat chronic hepatitis C (HCV).
According to the Director General of Health, Dr Noor Hisham Abdullah, Malaysia is the first country in the world to approve the use of Ravida with other drugs to treat HCV in adults.
The product was manufactured by Doppel Farmaceutici SRL in Italy, with Pharmaniaga Manufacturing Bhd as the local holder of the product registration, he added.
While the country was committed to eradicating HCV by 2030, Noor Hisham said, the cost of testing and current direct-acting antiviral (DAA) drugs was high.
“There is a need to find alternative solutions with effective and affordable treatments,” he said in a statement.
Noor Hisham also said the Department of Health has been working with the Drugs for Neglected Diseases Initiative (DCDi) since 2016 to reduce barriers to accessing hepatitis treatment in Malaysia.
He said the main outcome of this study was the HCV clinical trial of DNDi, known as STORM-C-1, conducted at six facilities in Malaysia and four in Thailand.
The test results were used as primary data for the product registration application and were also published in the journal “The Lancet Gastroenterology & Hepatology” on April 15th.