New Medication Awaiting FDA Approval

New Medication Awaiting FDA Approval

Thailand's Initiative to Combat Hepatitis C

The Government Pharmaceutical Organisation (GPO) in Thailand is making significant strides in the fight against hepatitis C by preparing to register an affordable drug called ravidasvir with the Food and Drug Administration. This move aims to enhance access to treatment for approximately 800,000 patients while significantly reducing the costs associated with their care.

Dr. Mingkwan Suphanpong, the director of GPO, announced on Thursday that the state producer is collaborating with two key partners: the Drugs for Neglected Diseases initiative (DNDi) and Pharco Pharmaceuticals, a company based in Egypt. These two entities co-developed ravidasvir under a South-South partnership, highlighting the importance of international collaboration in addressing global health challenges.

The three parties have signed a memorandum of understanding to provide technical documents and regulatory support, ensuring that the registration process moves forward smoothly. This agreement underscores the commitment of all involved to make ravidasvir available to those in need as quickly as possible.

Clinical trials conducted in Bangkok, Chiang Mai, and Malaysia have demonstrated that ravidasvir achieves cure rates exceeding 95%. The drug has already been registered in Malaysia and is listed on the World Health Organization's essential medicines roster. As a result, it will become Thailand's first domestically produced direct-acting antiviral (DAA) developed through international collaboration.

Dr. Mingkwan emphasized that current DAA regimens cost more than 2.5 million baht, which makes them unaffordable for many patients. Only about one in five Thais with the virus can currently afford therapy, she noted. Untreated hepatitis C infections can lead to severe complications such as liver cancer, cirrhosis, and chronic disease, placing a heavy burden on families and the healthcare system.

The registration of ravidasvir is a crucial component of Thailand's strategy to eliminate hepatitis C by 2030. This initiative aligns with global efforts to combat the disease and improve public health outcomes.

DNDi, an NGO focused on providing affordable medicines in developing nations, and Pharco Pharmaceuticals, which supplies the active pharmaceutical ingredient, will continue to support GPO in scaling up production once regulatory clearance is obtained. Dr. Mingkwan highlighted that a Thai-made version of ravidasvir would significantly lower prices and expand access to treatment.

This development marks a pivotal moment in Thailand's approach to hepatitis C. By leveraging international partnerships and focusing on affordability, the country is taking a proactive stance in improving healthcare access for its citizens. The successful registration and production of ravidasvir could serve as a model for other nations facing similar challenges in combating infectious diseases.

In conclusion, the introduction of ravidasvir represents a major step forward in the battle against hepatitis C. With the support of international partners and a commitment to affordability, Thailand is positioning itself as a leader in the global effort to eliminate this disease. The impact of this initiative is expected to be felt not only within the country but also across the region, inspiring similar efforts in other developing nations.

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