FDA clears Bayer’s Gadavist as first contrast agent for cardiac MRI

Bayer’s Gadavist has become the first imaging agent approved in the US to detect blockages in the hearts of patients with known or suspected coronary artery disease (CAD).

The magnetic resonance imaging (MRI) contrast agent – based on gadobutrol – has been cleared by the FDA for cardiac MRIs on the back of two phase 3 trials which showed it was safe and effective for that use.

Specifically, the regulator has approved Gadavist for use in conjunction with magnetic resonance angiography (MRA), to evaluate known or suspected supra-aortic or renal artery disease in adult and paediatric patients.

The new indication is the fourth for Bayer’s product and opens up a sizeable new market for the drug, which brought in sales of €366 million last year from its current usage in MRI studies of the brain, spine, breast, liver and kidneys.

Approximately 16.5 million Americans are affected by CAD, making it the most common form of heart disease.

CAD develops when the coronary arteries become damaged or diseased, resulting in the build-up of fatty plaques in the arteries and inflammation. Eventually the plaque can narrow the coronary arteries, decreasing blood flow to the heart, and raises the risk of a heart attack where blood flow is completely blocked.

Bayer says Gadavist – known as Gadovist in some markets – should help physicians to provide a more accurate and faster diagnosis for their cardiology patients compared to other diagnostics, without exposing them to radiation.

Using the imaging agent it is possible to get a clearer picture of the blood supply serving the heart muscle, together with how well the blood flows or perfuses through the muscle at rest and during exercise.

Scott Flamm, head of cardiovascular imaging at the Cleveland Clinic in the US, said the approval means “we now have an approved contrast agent for use in cardiac MR to assess perfusion and late gadolinium enhancement in less than one hour.”

There are risks associated with gadolinium-based contrast agents, however. In 2010, the FDA required a boxed warning for all agents in the class alerting physicians to the risk of nephrogenic systemic fibrosis, a potentially fatal side effect, in people who can’t eliminate the agent effectively, for example if they have kidney disease.

The regulator has also asked manufacturers to carry out additional studies on safety even in people with normal kidney function, after issuing an alert in 2017 about the possibility that gadolinium agents could be retained in the brain and other organs for years after dosing. It added however that the benefits of the contrast agents outweigh any potential risks.