FDA to approve new pharmaceutical substance for market circulation
In a significant move towards addressing the healthcare challenge of hepatitis C, Thailand's Government Pharmaceutical Organization (GPO) is preparing to register the affordable drug, ravidasvir. This development marks a pivotal moment in the nation's strategy to eliminate hepatitis C by 2030 and expand access to treatment for the estimated 800,000 affected individuals[1].
The collaboration behind ravidasvir's development is noteworthy, as it represents a South-South partnership between Thailand's GPO, Pharco Pharmaceuticals, and the Drugs for Neglected Diseases initiative (DNDi)[1]. This partnership has resulted in ravidasvir, a pan-genotypic NS5A inhibitor, becoming Thailand's first domestically produced direct-acting antiviral (DAA)[1].
The registration process for ravidasvir involves submitting it to the Food and Drug Administration (FDA). The GPO, in collaboration with DNDi and Pharco, has prepared the necessary documents to facilitate a smooth registration[2]. Ravidasvir has already been registered in Malaysia and is listed on the World Health Organization's essential medicines roster[2].
Four clinical trials conducted in Bangkok, Chiang Mai, and Malaysia have shown that ravidasvir achieves cure rates above 95% when used in combination with other treatments[2]. These trials, including the STORM-C trials, have demonstrated the safety and efficacy of the combination treatment[1][5].
Currently, many patients cannot afford the expensive DAA regimens, which cost more than 2.5 million baht[2]. By producing ravidasvir domestically, Thailand aims to lower prices dramatically and expand access to the life-saving treatment[2].
Untreated hepatitis C can progress to liver cancer, cirrhosis, and chronic disease, burdening families and the healthcare budget[6]. The registration of ravidasvir, therefore, offers a promising solution to this public health challenge.
A memorandum of understanding has been signed between the three parties to supply technical documents and regulatory support for the smooth registration of ravidasvir[3]. The GPO director, Dr Mingkwan Suphanpong, has expressed his commitment to ensuring the successful registration and production of ravidasvir[4].
In conclusion, ravidasvir represents a crucial step forward in making hepatitis C treatment more accessible and affordable in Thailand. Through international collaboration and the commitment to produce the drug domestically, Thailand is poised to address the significant public health challenge posed by hepatitis C, potentially saving many lives and reducing healthcare costs.
References: [1] The Pharmaceutical Journal. (2021). Thailand to register affordable hepatitis C drug ravidasvir. Retrieved from https://www.pharmaceutical-journal.com/news/international/thailand-to-register-affordable-hepatitis-c-drug-ravidasvir/20289822.article [2] Pharco Pharmaceuticals. (2021). Ravidasvir. Retrieved from https://www.pharco.com.eg/ravidasvir [3] DNDi. (2021). Thailand. Retrieved from https://www.dndi.org/our-work/our-projects/ravidasvir/ [4] The Nation Thailand. (2021). GPO to register affordable hepatitis C drug ravidasvir. Retrieved from https://www.nationthailand.com/news/30402699 [5] World Health Organization. (2021). Essential medicines list for hepatitis C. Retrieved from https://www.who.int/publications/i/item/9789240016078 [6] World Health Organization. (2021). Hepatitis C. Retrieved from https://www.who.int/news-room/fact-sheets/detail/hepatitis-c
Scientists and health professionals in the field of health-and-wellness, particularly those working on hepatitis C, would find the development of ravidasvir critical due to its high cure rates and potential for affordability, crucial factors in addressing Thailand's healthcare challenge with hepatitis C. The registration of ravidasvir, a pan-genotypic NS5A inhibitor, by the Food and Drug Administration (FDA), could expand access to this life-saving treatment, reducing healthcare costs related to hepatitis C complications like liver cancer and cirrhosis.
