EU drugs regulator backs Mounjaro's sleep apnea use without fresh approval for Lilly

 -The European Medicines Agency has allowed Eli Lilly to update the product label of its weight-loss drug Mounjaro to show it has benefit in treating a sleep disorder without approving it specifically for the disease, the company said.

Lilly was seeking EU approval for the expanded use of Mounjaro to treat moderate to severe obstructive sleep apnea (OSA) in patients with obesity.

The EMA said it did not believe the company needs a separate approval, highlighting that the disorder was closely related to obesity.

"OSA and obesity are two diseases that often overlap; about 58% of people with moderate to severe  OSA have excess weight," Lilly said.

In two trials involving 469 participants, Lilly's drug helped cut the frequency of irregular breathing in patients by as much as 63%, the company reported in April.

Lilly is also seeking approval for the drug in sleep apnea patients in the U.S. 

Lilly and Danish rival Novo Nordisk are racing to show that their obesity drugs also have other medical benefits. Approval for use beyond weight-loss could be a shot in the arm for the companies at a time when demand for the drugs is already surging. 

Obstructive sleep apnea affects roughly 1 billion people globally, according to a 2019 study published in The Lancet.

Common treatments include CPAP machines, which involve wearing a mask over the face while sleeping, surgery, as well as losing weight. 

Tirzepatide is sold as Mounjaro in Europe and is approved for patients with obesity and type 2 diabetes. Regulators can allow expanded use of treatments if new evidence shows them to be effective in new therapeutic areas.

https://www.marketscreener.com/quote/stock/NOVO-NORDISK-A-S-1412980/news/EU-drugs-regulator-backs-Mounjaro-s-sleep-apnea-use-without-fresh-approval-for-Lilly-48589624/

Ohio Senate passes bill forcing hospitals to administer ivermectin, other patient-requested treatments

 The Ohio state Senate passed a bill earlier this week that will allow patients to force hospitals to administer drugs for off-label use.  

The passage of the bill comes after a years-long effort by Republican lawmakers in the state to expand COVID-19 patients’ access to drugs like ivermectin and hydroxychloroquine, according to reporting from the Ohio Capital Journal. 

Multiple high-profile conservatives — including President-elect Trump — touted both drugs as alternative treatments for COVID-19.  

However, research shows that the drugs are ineffective in treating the disease and preventing hospitalizations. Ivermectin is an antiparasitic drug used to deworm animals, and hydroxychloroquine is a medication used to treat malaria. 

Under the bill, a prescriber can write a prescription for off-label use of a drug as long as they have the patient’s permission, anyone holding a patient’s power of attorney or in the case of minors, their parent’s or guardian’s permission.  

Hospitals, in-patient facilities and the pharmacists working within them are also required to dispense drugs for off-label use during public health emergencies as part of the bill.  

There are some caveats to the proposed rule, however, that would enable a prescriber to say no to issuing a drug for off-label use.  

Pharmacists, hospitals or inpatient facilities don’t have to issue drugs for off-label use if they have a “moral, ethical, or religious belief or conviction” that conflicts with dispensing a medication off label.  

They are not required to administer off-label medication if they have an “objective, good faith, and scientific” objection to the drug being used for anything other than what it is intended for, or if a pharmacist has documented that a patient is allergic to the drug or it could cause a life-threatening drug interaction.  

The bill will need to be approved by the Ohio House of Representatives before it can be sent to the governor.  

https://thehill.com/policy/healthcare/5037697-ohio-senate-passes-measure-forcing-hospitals-to-administer-ivermectin-other-patient-requested-treatments/

Texas sues out-of-state telehealth doctor for prescribing abortion pill

 

The lawsuit appears to be the first legal test to see what happens when contradictory state abortion laws meet.

Jay Janner/Austin American-Statesman via AP

Texas Attorney General Ken Paxton (R) is suing a New York doctor for prescribing and sending abortion medication to a Texas woman via telehealth, the first test of a blue state’s abortion shield laws.     The lawsuit alleges that New York doctor Margaret Daley Carpenter violated Texas law after she prescribed abortion medication to a 20-year-old Texan who later had an “adverse event” resulting in a medical abortion.     The Collins County woman was brought to the hospital more than a month after Carpenter allegedly prescribed her abortion medication due to heavy bleeding, according to the lawsuit.     It is unclear if the woman’s abortion was successful or what health consequences she might have suffered from it.   Abortion is almost completely banned in Texas, but residents can still access abortion medication via telehealth providers located out-of-state.     New York—along with a handful of other Democratic-led states—has shield laws to protect providers from out-of-state investigations and prosecutions if they prescribe and send abortion medication to people living in states with abortion restrictions.   But the laws have only been in existence for about a year and to date have never been tested in court.   Legal experts have said the true test will be whether New York’s courts recognize it, since this lawsuit is what the law was designed to protect against.    In response to Paxton’s lawsuit, New York Attorney General Letitia James (D) pledged to protect providers from “unjust” attacks.     “Abortion is, and will continue to be, legal and protected in New York,” James said in a statement. “We will always protect our providers from unjust attempts to punish them from doing their jobs and we will never cower in the face of intimidation or threats.”     Meanwhile, leading anti-abortion group Susan B. Anthony Pro-Life America said it hoped other states will follow Texas’s lead.     “We thank Attorney General Ken Paxton for leading the charge to hold out-of-state abortion businesses accountable,” SBA Director of Legal Affairs Katie Daniel said in a statement. “We hope his example will embolden other pro-life leaders and begin the undoing of the mail-order abortion drug racket.”  https://thehill.com/newsletters/health-care/5040096-texas-sues-out-of-state-telehealth-doctor-for-prescribing-abortion-pills/

Johnson briefed on drone sightings

 House Speaker Mike Johnson has received a classified briefing on the drone sightings, according to Kellie Meyer, Washington Correspondent at NewsNation.

A number of House and Senate lawmakers have called for briefings from state and federal officials as concerns rise about the unidentified lights flying over New Jersey and some nearby states, which many believe are drones of some sort.

https://thehill.com/homenews/5038749-drones-goverment-shutdown-trump-live-updates/

Trump calls for mystery drones to be shot down

 President-elect Trump on Friday evening called for authorities to shoot down the mysterious drones that have been seen in the skies of New Jersey and around the country.

He also suggested the government must know more about the mysterious sightings. 

“Mystery Drone sightings all over the Country. Can this really be happening without our government’s knowledge. I don think so! Let the public know, and now. Otherwise, shoot them down!!! DJT” the incoming president wrote on Truth Social.

The post comes as there have been mounting reports of sightings in New Jersey, New York and, according to Philadelphia’s WPVI-TV, multiple reports of flying objects within Delaware and Philadelphia counties.

The Pentagon on Wednesday denied that any foreign country was behind the mysterious drones that have flown near sensitive U.S. military sites in New Jersey.

Lawmakers from New Jersey and New York — areas that the mysterious drones have flown over — sent a letter Thursday to the FBI, Department of Homeland Security and Federal Aviation Administration demanding a briefing on the drones.

Sen. Kirsten Gillibrand and Senate Majority Leader Chuck Schumer, Democrats from New York, along with New Jersey Sens. Cory Booker (D) and Andy Kim (D) asked agencies how they are working “to identify and address the source of recent unmanned aerial system activity.”

House Speaker Mike Johnson (R-La.) received a classified briefing on the drone sightings earlier on Friday.

https://thehill.com/homenews/state-watch/5039992-trump-drones-shot-down/

Study Links Ozempic To Vision Loss, Confirms Harvard Research

 Another study has been published suggesting that patients taking semaglutide—the active ingredient in Novo Nordisk's blockbuster drug Ozempic—may face a higher risk of developing a rare eye condition that can lead to blindness. 

"The glucagon-like peptide 1 receptor agonist (GLP-1RA) semaglutide has quickly become a key treatment for managing type 2 diabetes and obesity. Recent findings have raised concern about a potential association between semaglutide use and non-arteritic anterior ischemic optic neuropathy (NAION)," according to a new Danish–Norwegian study, backing up similar results from a Harvard University study published in July. 

Non-arteritic anterior ischemic optic neuropathy, or NAION, occurs when blood flow to the optic nerve is blocked, causing sudden vision loss. 

Bloomberg first reported the results on Friday afternoon. The findings were initially published on Wednesday on medRxiv, an online platform for sharing research.

The results indicate that a type 2 diabetes patient taking Ozempic for two decades would have a .3% to .5% chance of developing NAION. 

"The vision loss is usually irreversible and there is no treatment. Given the serious nature of this potential adverse effect of semaglutide, we leveraged the nationwide Danish and Norwegian health registries to further investigate this association," according to authors from the University of Southern Denmark, Norwegian Institute of Public Health, and the University of Copenhagen.

The authors emphasized: "Given the well-established effects of semaglutide in managing both diabetes and obesity, it is crucial to weigh the potential risk of NAION against the substantial therapeutic benefits of semaglutide. While the association observed for the use of semaglutide in type 2 diabetes represents a two-fold or higher relative risk increase..." 

The Nordic study comes months after Harvard-affiliated Massachusetts Eye and Ear found the rising risk of Ozempic patients developing NAION. 

In Copenhagen, Novo shares slid as much as 5.4%. Since peaking in June at 1,000 Krone, shares have entered a bear market (-26%). 

Using Goldman's index of companies with high exposure to GLP-1s, the Trump dump pressured the index lower from nearly 40% gains on the year in late summer to hovering around 14% on Friday, while companies at risk from GLP-1s have steadily gained on the year, 13%.

In addition to the risk of vision loss, Ozempic and Wegovy users can also develop "Ozempic Face" after rapid body fat loss. 

https://www.zerohedge.com/medical/new-study-links-ozempic-vision-loss-confirms-harvard-research

'FBI, DHS Say "No Evidence" New Jersey Drones Pose National Security Threat'

 by Jack Phillips via The Epoch Times,

The FBI and Department of Homeland Security (DHS) responded to reports about drone sightings over the New Jersey area in the past several weeks, a phenomena that has raised alarm among local elected officials.

In a statement to The Epoch Times on Thursday evening, the FBI and DHS said the agencies “have no evidence at this time that the reported drone sightings pose a national security or public safety threat or have a foreign nexus.”

“The FBI, DHS and our federal partners, in close coordination with the New Jersey State Police, continue to deploy personnel and technology to investigate this situation and confirm whether the reported drone flights are actually drones or are instead manned aircraft or otherwise inaccurate sightings,” the statement reads.

Their statement did not go into more detail about the sightings in recent days. Several state and U.S. lawmakers in both New Jersey and New York have called on the federal government to release more information or take action regarding the drone sightings.

In several interviews this week, Rep. Jeff Van Drew (R-N.J.) warned that the drones may be Iranian in origin, which was denied by a Pentagon spokeswoman. White House national security spokesman John Kirby said Thursday that the drones do not pose a national security risk to the United States.

On Thursday, Van Drew disputed the Pentagon’s statement about Iran being unconnected to the drone sightings, doubling down on his previous claim. He said “high-level” anonymous U.S. officials provided him with that information, which is why he is going public with it.

That same day, Sens. Cory Booker (D-N.J.), Andy Kim (D-N.J.), Chuck Schumer (D-N.Y.), and Kirsten Gillibrand (D-N.Y.) sent a joint letter to DHS, the FBI, and the Federal Aviation Administration (FAA) to brief them on drone activity over New Jersey and New York.

“The potential safety and security risks posed by these drones in civilian areas is especially pertinent considering recent drone incursions at sensitive military sites in and outside of the continental United States over the past year,” they warned.

Separately, Sen. Richard Blumenthal (D-Conn.) told reporters that the drones should be “shot down, if necessary” and that the United States “should be doing some very urgent intelligence analysis and take them out of the skies, especially if they’re flying over airports or military bases.”

“The lack of information is absolutely unacceptable,” the senator said Thursday.

In their statement Thursday, FBI and DHS also cautioned that there have been “cases of mistaken identity” and that the drones might be “manned aircraft or facilities.”

In the meantime, DHS and the FBI are supporting New Jersey state and local law enforcement with detection capabilities “but have not corroborated any of the reported visual sightings with electronic detection.”

“To the contrary, upon review of available imagery, it appears that many of the reported sightings are actually manned aircraft, operating lawfully,” they said.

“There are no reported or confirmed drone sightings in any restricted air space.”

The FBI and DHS asserted that the two agencies “take seriously” any threats that could be posed by drones but stressed that officials “have uncovered no such malicious activity or intent at this stage” so far.

“While there is no known malicious activity occurring in New Jersey,” the agencies said, “the reported sightings there do, however, highlight the insufficiency of current authorities.”

Reports of drone sightings over the Garden State began in November, Van Drew and other New Jersey officials have said.

In early 2023, a high-altitude balloon that originated from China flew hundreds of miles across North America, passing near sensitive military sites, U.S. officials said at the time.

The U.S. Air Force ultimately shot down the balloon off the coast of South Carolina in early February of that year.

Multiple other balloon sightings were reported since then, with the U.S. military shooting down a balloon over Lake Huron near Michigan in February 2023.

https://www.zerohedge.com/political/fbi-dhs-say-no-evidence-new-jersey-drones-pose-national-security-threat