trending Market Intelligence /marketintelligence/en/news-insights/trending/YR3Kvprmws8_or19Mjr6OQ2 content
Log in to other products

Login to Market Intelligence Platform


Looking for more?

Contact Us

Request a Demo

You're one step closer to unlocking our suite of comprehensive and robust tools.

Fill out the form so we can connect you to the right person.

If your company has a current subscription with S&P Global Market Intelligence, you can register as a new user for access to the platform(s) covered by your license at Market Intelligence platform or S&P Capital IQ.

  • First Name*
  • Last Name*
  • Business Email *
  • Phone *
  • Company Name *
  • City *
  • We generated a verification code for you

  • Enter verification Code here*

* Required

Thank you for your interest in S&P Global Market Intelligence! We noticed you've identified yourself as a student. Through existing partnerships with academic institutions around the globe, it's likely you already have access to our resources. Please contact your professors, library, or administrative staff to receive your student login.

At this time we are unable to offer free trials or product demonstrations directly to students. If you discover that our solutions are not available to you, we encourage you to advocate at your university for a best-in-class learning experience that will help you long after you've completed your degree. We apologize for any inconvenience this may cause.

In This List

US FDA panel votes against approval of Correvio's irregular heartbeat drug

COVID-19 Pandemic Likely To Cause US Telemedicine Boom

Gauging Supply Chain Risk In Volatile Times

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry


IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help

US FDA panel votes against approval of Correvio's irregular heartbeat drug

Correvio Pharma Corp. said the U.S. Food and Drug Administration's cardiovascular and renal drugs advisory committee voted 11-2 against approval of its irregular heartbeat drug Brinavess.

The panel determined that the benefit-risk profile of Brinavess, or vernakalant, was not adequate to support approval. The FDA, which is expected to announce a decision on the drug's application by Dec. 24., considers the committee's recommendation but is not obliged to follow it.

Brinavess is approved in 41 countries outside the U.S., Correvio noted in its Dec. 10 press release.

Vancouver, British Columbia-based Correvio resubmitted a new drug application to the U.S. FDA in June after the regulator rejected a 2017 resubmission request for Brinavess. The agency deemed the earlier application insufficient.

The U.S. regulator accepted the Canadian drugmaker's resubmitted application for Brinavess in July to treat a type of atrial fibrillation, or an irregular heartbeat, in adults.

Atrial fibrillation increases the risk of stroke and heart failure. The American Heart Association expects that 12 million U.S. citizens will be affected by atrial fibrillation by 2030.

Correvio based the resubmitted application on results from a post-approval safety study called Spectrum, which was conducted with 1,778 patients in Europe. The trial showed that 70.2% of all patients treated with Brinavess saw their heart rhythm converted into a normal sinus rhythm.

Trading of Correvio's shares was halted on the Nasdaq and the Toronto Stock Exchange prior to the FDA's advisory committee meeting.