Weight reduction syringes of the brands “Wegovy”, “Ozempic” are sold at In der Achat Apotheke in Mitte, Germany.
Picture Alliance | Picture Alliance | Getty Images
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Novo Nordisk’s blockbuster weight reduction and diabetes drugs Wegovy and Ozempic are once more being linked to unintended uncomfortable side effects.Â
The weekly injections may, in very rare cases, cause a serious eye condition that may result in vision loss, the European Medicines Agency’s safety committee said Friday. It’s the primary time a regulator has confirmed the side effect following previous studies in Type 2 diabetes patients linking Ozempic to the condition, often called non-arteritic anterior ischemic optic neuropathy (NAION).
The committee has asked Novo Nordisk so as to add the attention condition as a side effect of “very rare” frequency within the product information for drugs that contain semaglutide. That is the lively ingredient in Wegovy, Ozempic and Novo Nordisk’s diabetes pill Rybelsus.Â
It’s the newest potential concern about popular GLP-1s reminiscent of Ozempic and Wegovy, which mimic gut hormones to control blood sugar and tamp down appetite. Demand for the drug class has soared despite hefty price tags and a handful of unpleasant uncomfortable side effects which might be mostly gastrointestinal, reminiscent of nausea and vomiting.
It likely won’t be an enormous concern for the overwhelming majority of patients: the attention condition may affect as much as 1 in 10,000 people taking semaglutide for no less than one 12 months, in response to the committee.Â
The committee said individuals with diabetes who’re exposed to semaglutide are at a twofold increase in the danger of developing NAION compared with those not taking it.Â
The attention condition is the second-most common explanation for blindness as a result of optic nerve damage, after glaucoma. It’s characterised by vision loss as a result of decreased blood flow to the front a part of the optic nerve, which connects the attention to the brain. The disease typically occurs with none pain and mostly affects people ages 50 and above.Â
The committee said patients should stop treatment with semaglutide products in the event that they experience the side effect. Since December, it has been reviewing the findings of two Danish studies linking Ozempic to the condition in diabetes patients.Â
In a press release, Novo Nordisk said it has concluded that the information “didn’t suggest an affordable possibility of a causal relationship between semaglutide and NAION.” The corporate said the advantages of semaglutide still outweigh its risks.Â
However the drugmaker said it is going to collaborate with the EMA to update the labels for semaglutide products.Â
A day before the committee’s statement, GLP-1s faced scrutiny over one other potential eye-related side effect.Â
A study, published Thursday in JAMA Ophthalmology and conducted by University of Toronto researchers, found that diabetes patients who use GLP-1 drugs were twice as more likely to develop neovascular age-related macular degeneration (nAMD) in comparison with those that don’t take the medications.Â
The study also found that the longer patients were treated with these medications, the greater their risk of developing nAMD.
nAMD, commonly often called “wet” AMD, is the less common but more aggressive type of age-related macular degeneration. It’s the leading explanation for irreversible vision loss amongst older adults within the U.S.
The researchers drew on health records from Ontario, Canada. They analyzed nearly 140,000 adults with Type 2 diabetes to analyze a possible link between GLP-1 use and wet AMD. Within the overwhelming majority of cases, patients received semaglutide.Â
Novo Nordisk said semaglutide’s “efficacy and safety have been extensively demonstrated in individuals with obesity/chubby with robust evidence for improving health outcomes.”
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Latest in health-care tech: Listed below are the health tech firms that made CNBC’s Disruptor 50 List
The Disruptor 50 designation is a ranked list of progressive private firms which might be advancing breakthrough technology inside their sector. Any private, independently owned startups that were founded after Jan. 1, 2010 were capable of be nominated.Â
Nominated firms needed to submit qualitative information, like descriptions of their core business model, which were assessed by a team of CNBC editorial staff. Additionally they needed to submit quantitative data, like sales and user numbers, which were evaluated by CNBC’s Disruptor 50 Advisory Board and Disruptor 50 VC Advisory Board.
Listed below are the health tech firms that earned a spot this 12 months:
- #14: Transcarent. Founded by longtime health-care executive Glen Tullman in 2020, Transcarent helps employees quickly access care and navigate advantages. The corporate has raised $940 million in total funding at a $3 billion valuation.
- #17: Virta Health. Sami Inkinen (CEO), Stephen Phinney and Jeff Volek founded Virta Health in 2014. The startup helps patients manage diabetes and obesity, and it has raised $364.5 million at a $2.1 billion valuation, in response to PitchBook.
- #23: Oura. This smart ring-maker has raised $200 million at a $5.2 billion valuation. The corporate was founded by Petteri Lahtela, Kari Kivelä and Markku Koskela and launched in 2013. The buyer and wearable technology company is now led by Tom Hale.
- #26: Iambic Therapeutics. Founded by Tom Miller (CEO) and Fred Manby, Iambic Therapeutics uses artificial intelligence to speed up the pace of drug discovery and development. The corporate launched in 2020 and has raised $220 million.
- #37: Formation Bio. Benjamine Liu (CEO) and Linhao Zhang founded Formation Bio in 2016. The corporate uses AI to speed up the clinical development of promising drug candidates. It has raised $600 million at a $1.7 billion valuation, in response to PitchBook.
- #41: Rad AI. This startup uses generative AI to avoid wasting radiologists time and enhance productivity. Doktor Gurson (CEO) and Jeff Chang founded the corporate in 2018. Rad AI has raised $143 million in funding at a $528 million valuation.
- #43: ElevateBio. David Hallal, Vikas Sinha and Mitchell Finer founded the genetic medicines company ElevateBio in 2017. The corporate has raised $1.3 billion and is now led by Ger Brophy. ElevateBio is advancing treatments for cancer, multiple sclerosis, diabetes, and other conditions.
- #47: Abridge. This startup uses generative AI to automate the clinical documentation that doctors and nurses handle. Founded by Dr. Shiv Rao (CEO) and Zack Lipton in 2018, Abridge has raised $462.5 million at a $2.7 billion valuation.Â
Perhaps unsurprisingly, a few of the most important players in AI took the highest five spots on this 12 months’s list. Anduril, an autonomous defense company, earned the primary spot, followed by OpenAI, Databricks, Anthropic and the design platform Canva.Â
Taken together, these five firms have a combined valuation of slightly below $500 billion, which is greater than the combined total valuation of virtually every past Disruptor 50 list of the last 12 years. An indication of the times, little question.Â
Read the complete Disruptor 50 List here. Read more in regards to the selection process here.
Be happy to send any suggestions, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.