Vancouver, British Columbia-based Correvio Pharma Corp. said it is exploring strategic alternatives for the business after a U.S. Food and Drug Administration committee voted against the company's irregular heartbeat drug Brinavess.
Correvio has retained Piper Jaffray to help in its review of the strategic alternatives.
On Dec. 10, the FDA's cardiovascular and renal drugs advisory committee voted 11-2 against the approval of Brinavess — a medicine that is approved in 41 countries outside the U.S. — citing the therapy's inadequate benefit-risk profile.
While the FDA is not required to follow the committee's vote, the recommendation is taken into consideration. The FDA is expected to decide on the medicine's approval by Dec. 24.
In the meantime, Correvio said it was planning to reduce its operating costs outside its core commercial business in Europe, and has formed a transaction committee within its board for that purpose. The company said it would concentrate its resources on only essential commercial and business development activities.
Correvio is estimating over $30 million in revenue in 2019 from its ex-U.S. commercial portfolio, which includes four approved and marketed branded products and one product candidate.