The Saudi Food and Drug Authority (SFDA) has issued official approval for AbbVie’s new, all oral, interferon-free treatment for hepatitis C.
The VIEKIRAX and EXVIERA treatments have been approved with or without ribavirin (RBV) for genotype 1 (GT1) chronic hepatitis C virus infections.
Additionally, VIEKIRAX has been approved with ribavirin for genotype 4 (GT4) chronic hepatitis C virus infections.
The SFDA granted approval less than three months after receiving approval from the European Commission, making Saudi Arabia one of the first countries in the Middle East to have access to this groundbreaking treatment.
The treatment was also approved by the US Food and Drug Administration in December 2014.
Estimates indicate that there are between 200,000 and 400,000 people living with hepatitis C in the Kingdom, with GT4 being the most prevalent at an estimated 61 percent, followed by GT1 at 25 percent.
VIEKIRAX and EXVIERA are considered to be vital in the efforts to address hepatitis C in the Kingdom.
In trials, the medication cured an overall 97 percent of GT1 chronic hepatitis C virus patients.
The swift approval of AbbVie’s treatment is the result of the SFDA’s efforts to approve medicines that will help improve health conditions for Saudis and protect them from chronic conditions like hepatitis C.
Thanking health authorities for its approval, Rami Fayed, general manager of AbbVie in Saudi Arabia, said: “After long years of research and development that resulted in cure rates of up to 100 percent and approvals in the US, Canada and Europe, AbbVie is proud to be the provider of the SFDA-approved hepatitis C treatment.
“We will continue to work in close partnership with the Saudi government to help realize our shared vision and priorities for the healthcare sector.”
Following SFDA’s approval, AbbVie is planning a hepatitis awareness campaign in collaboration with the Ministry of Health and various government and private institutions.
This article was first published in the Saudi Gazette on May 5, 2015.SHOW MORE