Project name: gadoterate meglumine
Disease: Central nervous system diagnostic agent
Peak sales estimate: North of $205 million
Approved: March 21
Guerbet's Dotarem has the distinction of becoming the seventh gadolinium-based contrast agent approved by the FDA for patients undergoing central nervous system-related MRI exams. But its March 2013 approval is noteworthy for a number of other reasons. For one thing, Dotarem is the only macrocyclic and ionic gadolinium-based version approved in the U.S. since its initial 1989 launch and subsequent rollout in Europe and around the world. It has also tested as a safer option than other similar products. The FDA is allowing clinicians to use the agent in children as young as age 2, a patient group for whom other gadolinum-based contrast imaging agents are often not used due to risk of kidney damage. Further, doctors at Winthrop University Hospital in Mineola, NY, noted its first U.S. use in September in an adult with borderline renal function.
"In the past, before the availability of Dotarem, we would not use contrast agents in patients with impaired renal function," Dr. Orlando Ortiz, the hospital's radiology chairman, said in a company statement issued at the time of the procedure. "The introduction of Dotarem, in our view, gives us a new option for these cases."
Guerbet, a French company focused almost entirely on contrast agents, has had a lot to crow about, considering that Dotarem is already a market leader nearly everywhere else. Its overseas clout could help it gain a major foothold in the U.S. As of 2012, Dotarem had claimed a 47% market share in Europe, the company said, and is also sold widely in Asia, Africa, the Middle East and South America. Not to be forgotten, Dotarem is also Guerbet's first major U.S. launch.
The injectable agent helps radiologists spot brain and spinal abnormalities. A pivotal clinical trial helped turn the tide toward U.S. approval: 245 adult and 38 pediatric patients as young as age 2 with suspected central nervous system abnormalities each received a baseline MRI minus Dotarem, and then another MRI with the Dotarem injection. What they found: Dotarem helped radiologists do a far better job spotting details of lesions.
It's hard to predict Dotarem's sales potential, but its entry into the U.S. market should supercharge its revenue climb. Evaluate Group calculated that Dotarem generated more than $175 million in global sales in 2010, but that number surpassed $205 million in 2011, a jump of more than 18%. The medical imaging professional website AuntMinnie.com noted that Guerbet generates more than $525.7 million in annual revenue, half of which comes from MRI agents including Dotarem, Endorem and Lumirem. And as the story noted, Guerbet expects that Dotarem will likely sell at a premium over its rivals, due to its relative safety profile.
Even so, Dotarem's approval carries with it plenty of safety warnings. Doctors are cautioned to avoid using it with patients who have acute kidney injury or are at high risk of nephrogenic systemic fibrosis. -- Mark Hollmer (email | Twitter)
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