Dr. Steven Nissen, the Cleveland Clinic’s high-profile cardiovascular medicine chair, is staking his reputation as a drug-safety advocate on a shortened regulatory pathway for a cholesterol-fighting drug made by a Swedish company, according to a report in the May 31 issue of Bloomberg Businessweek.
Nissen is interested in eprotirome, developed by Karo Bio AB, because in combination with Pfizer’s Lipitor, the drug lowers cholesterol more than Lipitor alone. But because eprotirome works in a novel way, regulators like the Food and Drug Administration (FDA) require patient testing that could take five years and $500 million — time and money that small biotech company Karo Bio doesn’t have, Bloomberg said.
Enter, Nissen, the doctor who is a frequent adviser to the FDA and who warned early about the dangers of arthritis painkiller Vioxx, which was pulled from the market, and more recently, the dangers of diabetes drug Avandia.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Nissen, who has said for some time that new drugs to treat high cholesterol are needed, is now on the side of a drug developer. He’s endorsing a clinical trial for eprotirome that could cut its length and cost in half, according to Bloomberg.
Nissen and Karo Bio would have to persuade the FDA to go along with the trial proposal, and Karo would need to find a big drug company partner to help pay for the study, Bloomberg reported.
“What we are trying to do is look for a strategy that allows the company to move forward in a deliberative fashion to develop the data they need without costing half-a-billion dollars,” Nissen told Bloomberg. “That requires innovative thinking.”
