- The FDA on Monday granted priority review status to Sanofi/Regeneron's Biologics License Application (BLA) for Praluent (alirocumab), a PCSK9-inhibiting monoclonal antibody meant for treatment of patients with high cholesterol.
- The target action PDUFA date for the priority review is July 24, 2015.
- The EMA also accepted a marketing authorization application for alirocumab earlier this month. Now, with the FDA priority review, Sanofi and Regeneron have a major advantage over a competing investigational PCSK9 candidate from Amgen, evolocumab. Pfizer also has a candidate in this therapeutic class.
One of the most anticipated drug launches of 2015 just came one step closer to becoming a reality. Some analysts predict that alirocumab could be raking in more than $2.1 billion in sales by 2020. And considering pharma's strong first-to-market advantage, winning this priority review is a major win for Sanofi and Regeneron.
That doesn't mean the marketing battle here is settled. As benefits management giant Express Scripts' CEO George Paz told attendees at the JP Morgan Healthcare Conference in San Francisco earlier this month, PCSK9 inhibitors are already in his sights for price-cutting. So Amgen or Pfizer could still make a play for market share in exchange for a discount.