NEW YORK (AP) — A drug candidate used to restore a steady heartbeat received a recommendation for approval in Europe, according to Merck and Co. and Cardiome Pharma Corp.
The companies said Friday the Committee for Medicinal Products for Human Use said Brinavess should be approved as a treatment for recent onset atrial fibrillation in adults. Atrial fibrillation is a condition that causes the upper chambers of the heart to beat rapidly and ineffectively.
The recommendation improves the chances that European Union regulators will approve Brinavess for sale in the 27 EU countries, along with Norway and Iceland. Regulators will complete a review of the drug later this year.
Brinavess, or vernakalant, is delivered by infusion. Merck and Cardiome are also working on an oral version of the drug. The companies have also applied for U.S. approval of the infusion form of the drug.
A competing drug, Sanofi-Aventis’ Multaq, was approved in 2009.
Separately, Merck said the committee made a decision on its drug candidate Sycrest. The committee recommended that Sycrest be approved as a treatment for treating moderate to severe episodes associated with bipolar disorder in adults. However the committee did not recommend approval of Sycrest, or asenapine, as a treatment for schizophrenia.
Merck is headquartered in Whitehouse Station, N.J., and Cardiome is based in Vancouver, British Columbia.
