(Reuters) - U.S. Food and Drug Administration staffers reviewing Correvio Pharma Corp’s heart drug said on Friday they did not believe the benefits of the therapy outweighed its risks, sending the company’s shares down nearly 38%.
The drug, Brinavess, approved in Europe and other countries including Canada, aims to correct erratic heart rhythm in the upper heart chambers due to a condition known as atrial fibrillation or AFib.
Although Correvio has provided evidence of benefits, Brinavess comes with "serious liabilities" including low blood pressure, irregular heartbeats in the lower heart chambers, and death, the FDA staffers said in documents released on Friday. (bit.ly/2LvQSSl)
They also said the risk and management data provided by Correvio did not provide reassurance about the safe use of Brinavess.
A panel of independent experts to the FDA is set to convene on Tuesday to vote on the drug’s approval - an influential factor in the agency’s final decision that is expected by Dec. 24.
“While the company and its advisors will present its side... and bring experts to the (meeting) who will say that Brinavess is needed and can be used safely, we believe based on the FDA review to date, the odds are stacked against Brinavess,” Bloom Burton Securities analyst David Martin said.
Safety concerns led the FDA to decline approval to Brinavess in 2006 and later put trials on clinical hold as a patient with no apparent heart issues died after being administered Correvio’s drug. The hold still remains in place.
AFib, a common cardiac rhythm disturbance, is a leading cause of stroke. The condition affects about 2.7 million to 6.1 million Americans every year, according to the American Heart Association.
“Despite the cautious tone of the materials, we still believe there is a large unmet need for a drug like Brinavess and we are hopeful the Agency can find a path to approval,” Cantor Fitzgerald analyst Louise Chen said in a client note.
Current treatments for AFib include medication to regulate heart rhythm, blood thinners to prevent clot formation, and even, electric shocks to reset the heartbeat.
U.S.-listed shares of the Canadian drugmaker were trading lower at $1.32 in early morning trading.
Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Shounak Dasgupta and Shinjini Ganguli