LONDON – On Wednesday, Novo Nordisk (NYSE: NVO) said it is aware of 10 deaths and 100 hospitalizations resulting from people taking compounded copies of its weight-loss and diabetes drugs, and the CEO said he is alarmed by the risks of the unregulated copycat versions.
U.S. regulations allow compounding pharmacies to copy brand-name medicines that are in short supply by combining, mixing, or altering drug ingredients to meet demand.
Novo Nordisk’s popular weight-loss injection Wegovy and diabetes drug Ozempic, both known chemically as semaglutide, were until recently in shortage in the United States.
Given all the U.S. regulatory surveillance of Novo Nordisk’s production of the two drugs, CEO Lars Fruergaard Jorgensen said it was puzzling that people in the United States could inject themselves with a product that was not regulated, approved, or inspected.
“It beats me,” he told Reuters in an interview after the company reported better-than-expected third-quarter results. “I think this is something that will change over time,” he said of the oversight for compounded versions of Wegovy.
He added that the copycat versions were being sold online and through so-called “health spas”, rather than through the formal supply chain where Novo Nordisk and chief rival Eli Lilly (NYSE: LLY) sell their approved medicines.
Last month, Novo Nordisk (NYSE: NVO) asked the U.S. FDA to ban compounding pharmacies from making copycat versions of Wegovy and Ozempic, which it said were too complex for those manufacturers to produce safely.
MULTIPLE SAFETY CONCERNS
Earlier on Wednesday, Novo Nordisk’s Chief Financial Officer Karsten Munk Knudsen told a media briefing that the company had been looking at a number of compounded products in the market and identified multiple safety concerns as well as reports of hospitalizations and deaths.
Jorgensen noted that this safety reporting on compounded versions was not done through the FDA’s adverse events system.
Although all dose strengths of Ozempic and Wegovy are now listed as available on the FDA website, the drugs remain on the agency’s shortages list.
This was a result of significant investments to expand its manufacturing capacity and ongoing communication with the FDA, the company said at the time.
“This is an ongoing dialogue with the FDA. I don’t want to speculate today whether we’re completely off the shortages list, but this is a first step and we’re hopeful that we’ll be getting off in the future,” Knudsen told the media briefing on Wednesday.
He said that is important because if a product is not on the shortages list, there are limitations for compounding pharmacies making copycat versions.
(Source: Reuters)
