UAE Ministry of Health Authority Grants conditional Approval of AbbVie's Treatment of Hepatitis C in UAE

UAE Ministry of Health Authority Grants conditional  Approval of AbbVie’s VIEKIRAX® + EXVIERA for  the Treatment of Chronic Genotype 1 and Genotype 4 Hepatitis C in United Arab Emirates

• In Phase 3 clinical trials, VIEKIRAX^® + EXVIERA^® (with or without ribavirin) cured 95-100 percent of genotype 1 chronic hepatitis C virus  infected patients
• VIEKIRAX^® + EXVIERA^® was evaluated in more than 2,300 patients in over 25 countries, demonstrating consistently high cure rates across a large and diverse patient population

UAE, June 4, 2015 - AbbVie today announced that the UAE Ministry of Health (MoH) Authority has conditionally approved its all-oral, interferon-free treatment of VIEKIRAX^® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA^® (dasabuvir tablets). The treatment has been approved  globally with or without ribavirin (RBV) for genotype 1 (GT1) chronic hepatitis C virus (HCV) infection. Additionally, VIEKIRAX has been approved with RBV for genotype 4 (GT4) chronic HCV infections. The UAE MoH granted conditional approval of AbbVie’s VIEKIRAX + EXVIERA less than  six months after receiving approval from the European Commission, which makes the UAE one of the first countries in the Middle East to have potential  access to this groundbreaking treatment. The treatment was also approved by the U.S. Food and Drug Administration for GT1 chronic HCV infection in December 2014.

Hepatitis C represents a major global health problem, affecting more than 160 million worldwide. According to estimates from the latest local survey conducted by the MoH in the UAE, more than one percent of the UAE population and up to two percent of the expatriate community are living with chronic hepatitis C. Genotype 4 is the most common  genotype, representing an estimated 61 percent of chronic hepatitis C cases in the country (*1). The approval of VIEKIRAX + EXVIERA is considered a milestone in the efforts  of the UAE authorities to address the burden of hepatitis C in UAE. The swift approval of AbbVie’s treatment is the result of the MOH’s commitment towards approval of medicines that will help improve health conditions for UAE patients by effectively addressing chronic diseases like hepatitis C.

Dr. Mohamed AlZaabi, head of Zayed Military hospital said HCV as a disease is a significant burden both at social and medical levels, with a significant impact on patients’ lives. The prevalence of the HCV infection among UAE nationals is 1 to 2 percent (up to 20,000 patients) and the prevalence among expatriates is estimated to be between 1.5 to 2 percent, which leads to an additional 16,000 to 18,000 HCV infected patients living in the country.

Following the huge efforts of non-governmental organizations in the  UAE addressing the hepatitis C burden, AbbVie had the opportunity to hear from Mr. Khamis Mohammed Al Suwaidi, Manager, UAE Red Crescent Society - Sharjah, UAE speaking about the Red Crescent experience in this field: “Red Crescent plays a major role in treating underprivileged HCV  patients in the UAE. Addressing our patients’ need for cure and having the right care model for them is our main interest and ultimate goal.”

“AbbVie is proud to provide a groundbreaking treatment that offers high cure rates for people living with hepatitis C in the UAE,” said Abboud Bejani, regional vice president, Middle East Africa Pakistan , AbbVie. “We would like to thank the local regulatory authorities for their rapid response in giving their initial approval for VIEKIRAX + EXVIERA, a decision which reflects the value our hepatitis C treatment brings to people living with HCV. We will continue to work in close partnership with the UAE Government to help realize our shared vision and priorities for the country’s healthcare sector.”

Robust Clinical Program

The approval of VIEKIRAX + EXVIERA is supported by a robust clinical development program designed to study the safety and efficacy of the treatment in more than 2,300 enrolled patients across 25 countries, including the UAE. The program consisted of six pivotal Phase 3 studies, which demonstrated that VIEKIRAX + EXVIERA cured 95-100 percent of hepatitis C patients with genotype 1 hepatitis C virus (HCV) infection who received the recommended regimen, with less than 2 percent of patients experiencing virologic failure. Additionally, more than 98 percent of patients in clinical trials completed a full course of therapy. Most common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with ribavirin (RBV) were fatigue and nausea. Patients who achieve a sustained virologic response (SVR₁₂) are considered cured of hepatitis C.

Approval of VIEKIRAX in genotype 4 chronic HCV was based on a Phase 2 study in which patients treated with VIEKIRAX with RBV achieved 100 percent SVR₁₂.