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In a historic step for the Egyptian pharmaceutical industry that reinforces its global leadership, the Thai Food and Drug Administration (Thai FDA) has officially approved Ravidasvir as a safe and effective treatment against the hepatitis C virus (HCV).
This approval is part of a robust clinical and regulatory ecosystem spearheaded by the Thai FDA, organically linked with the Government Pharmaceutical Organization (GPO), scientific expertise centres, and clinical trial sites in prestigious Thai hospitals and institutions, including King Chulalongkorn Memorial Hospital, Bamrasnaradura Infectious Diseases Institute, Nakornping Hospital, and Maharaj Nakorn Chiang Mai Hospital.
The drug has demonstrated clinical efficacy in Thailand and Malaysia when used as a combination therapy, taken orally once daily for 12 weeks alongside the antiviral sofosbuvir, resulting in the patient's complete cure.
The research, development, and pharmaceutical manufacturing of this drug were driven by Pharco Pharmaceuticals, the Malaysian Ministry of Health, the Thai Ministry of Public Health, and DNDi.
Commenting on this breakthrough, Dr Sherine Helmy, Chairman of Pharco Pharmaceuticals, stated: "The approval of Ravidasvir for the treatment of viral hepatitis C represents a strategic addition to the global efforts aimed at eliminating HCV. I look forward to seeing this close collaboration with our partners contribute to providing an effective treatment for a broader segment of patients, bringing us closer to an HCV-free world, and ensuring that all patients are empowered to access this safe and effective drug."
Data indicate that there are approximately 350,000 people living with chronic HCV infection in Thailand, while World Health Organization (WHO) statistics show that 50 million people are infected globally.