AbbVie submits for EU marketing authorization its investigational, all-oral, interferon-free therapy for the treatment of chronic hepatitis C

AbbVie (NYSE: ABBV) submitted marketing authorization applications (MAAs) to the European Medicines Agency (EMA) seeking approval for the company’s investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. The MAAs are supported by data from the largest all-oral, interferon-free clinical program in GT1 patients conducted to date¹, which consists of six Phase III studies that include more than 2,300 patients in over 25 countries.

“These regulatory submissions bring us closer to offering adult genotype 1 chronic hepatitis C patients an all-oral, interferon-free regimen which has the potential to provide a promising advancement for the hepatitis C community in the European Union,” said Scott Brun, M.D., vice president, Pharmaceutical Development, AbbVie. “This regulatory milestone, on the heels of our submission of a New Drug Application in the U.S., represents an important step for our pipeline.”

Accelerated Assessment Granted

The EMA has granted AbbVie’s request for accelerated assessment for ABT-450/ritonavir, ombitasvir (ABT-267), and dasabuvir (ABT-333), a designation that is granted to new medicines of major public health interest. Review of AbbVie’s MAAs will be conducted under the centralized licensing procedure which, when finalized, provides one marketing authorization in all 28 member states of the European Union (EU). Although accelerated assessment could shorten the EMA’s review time by approximately two months, it does not guarantee a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) or final approval by the European Commission. If approved, ABT-450/ritonavir, ombitasvir (ABT-267), and dasabuvir (ABT-333) could be available for marketing in the EU in the first quarter of 2015.

Globally, approximately 160 million people are chronically infected with hepatitis C² and an estimated 3 million to 4 million people are newly infected each year.³ In Europe, approximately 17.5 million people have chronic hepatitis C,⁴ with GT1 as the predominant genotype.⁴

References

¹ Comparison based on review of data from www.clinicaltrials.gov for phase 3a programs of Gilead, BMS and BI as of November 15, 2013.
² Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011; 17(2):107-15.
³ World Gastroenterology Organisation. World Gastroenterology Organisation Global Guidelines: Diagnosis, Management and Prevention of Hepatitis C. April 2013. http://www.worldgastroenterology.org/assets/export/userfiles/WGO_Hepatitis%20C_Final%20Version.pdf. Accessed April 25, 2014.
⁴ EASL Clinical Practice Guidelines: management of hepatitis C virus infection. European Association for the Study of the Liver. J Hepatol. 2014;60:392-420.