- The European Medicines Agency (EMA) has recommended approval of AbbVie's new hep C three-in-one cocktail.
- If approved, the drug will be marketed as once-a-day Viekirax and twice-daily Exviera. This combination has been successful in clinical trials, eradicating hepatitis C virus in patients with all genotypes.
- The FDA is expected to have a decision on AbbVie's hep C combo by mid-December.
AbbVie's new hep C combo drug is comprised of a suite of drugs with various targets that effectively eradicates the virus across genotypes. Many experts see AbbVie gaining rapid traction in the market by undercutting Gilead's $94,500 price tag for Harvoni (sofosbuvir/ledapasvir).
Europe isn't the only market where this battle is heating up. Earlier this month, BioPharma Dive reported that the Chief Medical Officer of U.S. pharmacy benefits giant Express Scripts said the company is actively looking for a cheaper alternative to Sovaldi/Harvoni, and that AbbVie's next-gen hep C products are in its sights.
AbbVie co-developed its new combo product with Encanta Pharmaceuticals, which is slated to receive double-digit royalties. Analysts are forecasting peak sales in the $3 billion range.