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Correvio crumbles as FDA panel rejects AFib drug

Panel voted 11 to two against approval of drug

FDA building

Shares in Correvio have fallen sharply after an FDA advisory committee said it wouldn’t recommend approval of Brinavess, its ill-fated drug for atrial fibrillation, citing safety concerns.

The panel by 11 to two concluded that the potential risks with Brinavess (intravenous vernakalant) outweighed its efficacy in reducing disturbed heart rhythm in patients with acute AFib, making it highly unlikely that the FDA will deliver an early Christmas present to Correvio and approve the drug by the scheduled 24 December action date.

Advisory committee members said they had various concerns about Brinavess’ safety, pointing to cases of low blood pressure, arrhythmia in the lower chambers of the heart and fatalities with the drug in clinical trials.

Trading in Correvio shares was suspended ahead of the vote, but were down 57% in after-hours trading as investors in the biotech reacted to the news, and analysts speculated that the company may have to consider “strategic alternatives”.

Brinavess is an anti-arrhythmic drug that blocks potassium and sodium channels in the upper heart chambers, and has been in development by Correvio (formerly Cardiome) for many years.

Merck & Co/MSD bought into the programme in 2009 and initially sold the IV drug in Europe after an EMA approval in 2020, but handed back rights to that product – plus an oral formulation – in 2012.

Another former partner – Astellas – filed the drug for US approval in 2006, but that application was knocked back, and further testing was placed on hold by the FDA after a patient death in a clinical trial. That restriction is still in place, and the FDA also rejected another attempt to file in 2017.

Cardiome’s latest application is based on a post-marketing safety study called SPECTRUM that was conducted in Europe.

“We are disappointed with today's outcome because we believe in the strength of the data we presented today for Brinavess,” said Correvio’s chief executive Mark Corrigan.

“The treatment landscape is currently missing a rapid, efficacious and well tolerated option to treat patients with recent onset atrial fibrillation and we believe Brinavess has the potential to fill that unmet medical need,” he added.

Panellist Barry Davis of the University of Texas School of Public Health said that he voted against the drug because of the risks, noting that: “If this were the only drug or treatment around, yes, but there are other options,” reports Reuters.

11th December 2019

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