Novo Nordisk is aware of 10 deaths from compounded weight-loss drug copies
Adds details, background from paragraph 3
By Maggie Fick and Jacob Gronholt-Pedersen
LONDON, Nov 6 (Reuters) -Novo Nordisk NOVOb.CO is aware of 100 hospitalizations and 10 deaths resulting from people taking compounded copies of its popular weight-loss and diabetes drugs, the drugmaker's finance chief said on Wednesday.
Chief Financial Officer Karsten Munk Knudsen told a media briefing after the company released third-quarter results that the company had been looking at "a number of compounded products in the market and identified multiple safety concerns" as well as the reports of hospitalizations and deaths.
Last month, Novo Nordisk 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.
U.S. regulations allow compounders to copy brand-name medicines that are in short supply by combining, mixing or altering drug ingredients to meet demand. Wegovy and Ozempic, both known chemically as semaglutide, were until recently in shortage in the U.S.
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 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.
Knudsen reiterated that Novo Nordisk is "highly concerned about product safety" and that is why it is focused on compounded products in the market and related safety concerns.
Reporting by Maggie Fick; Editing by Jan Harvey, Emelia Sithole-Matarise and Louise Heavens
Latest News
Disclaimer: The XM Group entities provide execution-only service and access to our Online Trading Facility, permitting a person to view and/or use the content available on or via the website, is not intended to change or expand on this, nor does it change or expand on this. Such access and use are always subject to: (i) Terms and Conditions; (ii) Risk Warnings; and (iii) Full Disclaimer. Such content is therefore provided as no more than general information. Particularly, please be aware that the contents of our Online Trading Facility are neither a solicitation, nor an offer to enter any transactions on the financial markets. Trading on any financial market involves a significant level of risk to your capital.
All material published on our Online Trading Facility is intended for educational/informational purposes only, and does not contain – nor should it be considered as containing – financial, investment tax or trading advice and recommendations; or a record of our trading prices; or an offer of, or solicitation for, a transaction in any financial instruments; or unsolicited financial promotions to you.
Any third-party content, as well as content prepared by XM, such as: opinions, news, research, analyses, prices and other information or links to third-party sites contained on this website are provided on an “as-is” basis, as general market commentary, and do not constitute investment advice. To the extent that any content is construed as investment research, you must note and accept that the content was not intended to and has not been prepared in accordance with legal requirements designed to promote the independence of investment research and as such, it would be considered as marketing communication under the relevant laws and regulations. Please ensure that you have read and understood our Notification on Non-Independent Investment. Research and Risk Warning concerning the foregoing information, which can be accessed here.
