(Bloomberg) -- The Danish Medicines Agency said it would ask European authorities to review two new studies that point to a link between Novo Nordisk A/S’s blockbuster shot Ozempic and a rare form of vision loss.
The national regulator will call on the European Committee for the Evaluation of Adverse Reactions, or PRAC, to assess the Danish registry studies, the agency said Monday.
A pair of large studies from the University of Southern Denmark “strengthen the suspicion” of a link between Ozempic and the rare eye condition, called NAION, the agency said.
Conducted independently, the studies both found that people who took Ozempic faced more than twice the risk of the eye condition, which can cause blindness. Both appear to confirm a link first suggested earlier this year in a Harvard University study. However, the overall rate of the condition was low.
“Our products are out in millions of patients, so when you’re out in such large groups of patients, you see different underlying diseases in that population,” Novo Chief Executive Officer Lars Fruergaard Jorgensen said on Monday. Novo hasn’t seen such a risk emerge in its own studies, he said.
The drugmaker said it had thoroughly reviewed both studies and done its own internal safety assessment, finding that the benefit-risk profile of Ozempic is unchanged. NAION is not currently listed as a side effect of the drug on its label.
Novo’s shares were up 1.5% at 12:46 p.m. in Copenhagen, after paring earlier gains. The stock has risen about 10% this year.
One of the two studies to prompt the call for a review appeared last week on medRxiv, a website that posts studies before they’re reviewed by outside scientists. A Danish-Norwegian team used years of patient data from tens of thousands of people who’d taken Ozempic, finding 1.4 additional cases per 10,000 years of patient observation among people who took the treatment compared with those who took another diabetes drug.
The second study examined data from about 424,000 Danish diabetes patients, of whom a quarter received Ozempic, and has been accepted for publication in the International Journal of Retina and Vitreous.
“Where we used to see 60 to 70 cases of NAION per year, we now see up to 150,” Jakob Grauslund, a professor of opthalmology who led the 424,000-person study, said in a statement. “We have noticed that it is now more often patients with type 2 diabetes who come to the hospital due to NAION.”
The Danish regulatory agency received 19 local reports of NAION in patients who’d taken Ozempic and Wegovy through Dec. 10, said spokesperson Mia Jorgensen. The first Danish report of the rare condition as a suspected side effect of semaglutide, the active ingredient in both medicines, came in July.
NAION occurs when a loss of blood flow damages the optic nerve, and is most common in people over the age of 50. Though rare, the eye condition is irreversible, untreatable and potentially blinding, and doctors have said that patients should be informed of a possible risk.
--With assistance from Sara Sjolin.
(Updates with CEO comment in the fifth paragraph)
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