Burger line Burger line Burger line
Logo Logo Logo
Burger line Burger line Burger line
Sign in
Sign in

Correvio's heart drug fails to get FDA approval

(Reuters) - The U.S. Food and Drug Administration has declined to approve Correvio Pharma Corp’s drug to correct irregular rhythm in the upper chambers of the heart, the company said on Tuesday.

In the so-called complete response letter, the FDA stated that while the submitted data provides substantial evidence of the drug’s effectiveness, the data does not provide reassuring evidence of Brinavess’ safety, the company said.

A panel of independent experts to the FDA earlier this month voted 11-2 against approving Brinavess, citing serious safety risks, including low blood pressure and irregular rhythm in the lower heart chambers during the trials.

Brinavess, currently available in 41 countries including the European Union and Canada, aims to restore normal heart rhythm in patients facing erratic rhythm due to a condition called atrial fibrillation or AFib.

The company said it intends to request a meeting with the FDA as soon as possible to discuss the design and specifics of a potential study to address the agency’s concerns.

A day after the FDA panel’s recommendation, Correvio said it was exploring options including a sale. The company’s U.S.-listed shares fell as much as 67% on the day. They were down 7% at 37 cents before the opening bell on Tuesday.

AFib is a common cardiac rhythm disturbance that can lead to serious problems such as stroke and heart failure if left untreated.

Current treatments include medicines to regulate heart rhythm, blood thinners to help prevent clot formation, and, in some cases, electric shocks to reset the heartbeat.

Correvio has been trying to get U.S. nod since 2006, but the FDA declined approval over safety concerns and later put the U.S. studies on hold after the death of a patient. The hold still remains in place.

DECEMBER 24, 2019


0
Cart Subtotal:
Go to cart
You will be able to Pay Online or Request a Quote

We use "cookies*  to ensure the functionality of our website, recognise your browser or device, learn more about your interests, and provide you with essential features and services and for additional purposes, including:

Recognising you when you sign-in to use our services. This allows us to provide you with product recommendations, display personalised content, and provide other customised features and services.
Keeping track of your specified preferences. You may set your preferences through Your Account..
Keeping track of items stored in your shopping basket and personal cabinet.
Conducting research and diagnostics to improve ChemDiv’s content, products, and services.
Delivering content, including ads, relevant to your interests on ChemDiv’s site
Reporting. This allows us to measure and analyse the performance of our services.

By  cookies you give consent to the processing of your personal data, including transfer to third parties. Further information can be found in our privacy policy.

Accept all cookies