The Government Pharmaceutical Organisation (GPO) has prepared to register the affordable hepatitis C drug ravidasvir with the Food and Drug Administration to improve access for 800,000 patients and reduce treatment costs.
GPO director Dr Mingkwan Suphanpong said on Thursday that the state producer is working with the Drugs for Neglected Diseases initiative (DNDi) and Egypt‑based Pharco Pharmaceuticals, which co‑developed ravidasvir under a South‑South partnership.
The three parties have signed a memorandum of understanding to supply technical documents and regulatory support "so the registration proceeds smoothly", she said.
Four clinical trials conducted in Bangkok, Chiang Mai, and Malaysia show that ravidasvir achieves cure rates above 95%.
Already registered in Malaysia and listed on the World Health Organization's essential medicines roster, the drug will become Thailand's first domestically produced direct‑acting antiviral (DAA) developed through international collaboration, said Dr Mingkwan.
"Current DAA regimens cost more than 2.5 million baht, so many patients are left untreated," she said.
Only about one in five Thais with the virus can presently afford therapy, she added, yet untreated infection can progress to liver cancer, cirrhosis and chronic disease, burdening families and the health‑care budget.
Ravidasvir's registration is a central plank of Thailand's strategy to eliminate hepatitis C by 2030.
DNDi, an NGO dedicated to affordable medicines in developing nations, and Pharco, which supplies the active pharmaceutical ingredient, will continue to assist GPO in scaling up production once regulatory clearance is secured, she said.
Dr Mingkwan said a Thai‑made version of ravidasvir would "dramatically lower prices and expand access".