The company logo is located on March 17, 2024 outside the Eli Lilly headquarters in Indianapolis, Indiana.
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Yililai Its highest dose was said on Thursday Daily obesity medicine In an advanced trial, helping patients lose nearly 12% of their weight (about 27 pounds), that is, entering the market, paved the way.
The company’s shares fell more than 12% in Thursday’s listing trading.
Some doctors say the results seem to be with Novo NordiskObesity is a weekly injection of Wegovy.
The data are some Wall Street analysts’ expectations for Eli Lilly’s oral GLP-1, hoping to lose about 15% of weight. Some doctors also noticed the highest number of patients in the pill for side effects or any other reason in the trial.
Still, other doctors praised the pill for its outcomes and potential to cover new patients, such as those who fear needles.
“This is a strong and promising result for oral agents,” said Dr. Jaime Almandoz, medical director of the Weight Health Program at UT Southwest Medical Center. “This is a strong and promising result for oral agents, saying weight loss is an important and clinically significant outcome.”
He continued: “Injections set high standards, but this study enhances the transformative potential of oral GLP-1 in obesity care, especially for those who are reluctant to start or maintain injectable therapy.”
Dr. Mihail “Misha” Zilbermint, a doctor at the Johns Hopkins Community Doctor Endocrinology Hospital, said he believes the drug has the potential to change the game as long as people can tolerate side effects. ”
The results of the trial are one of the most closely watched studies of the pharmaceutical industry this year and follow Positive data from the third phase of April trial Testing for diabetic patients. They brought Eli Lilly’s Pill (Orforglipron) to the first new, needle-free alternative to the thriving weight loss market and the diabetes drug called GLP-1.
Eli Lilly hopes to submit the data to regulators by the end of this year and plans to launch pills in 2026, Ken Custer, president of Nuclear Metabolic Health at Eli Lilly, said in an interview.
The launch could fundamentally transfer the space, helping more patients get treatment and alleviate the inadequate supply of existing injections. More convenient and easier-to-made pills can also help Eli Lilly consolidate its strengths in the growing segment, including other drugmakers, including its major competitor Novo Nordisk, to bring weight loss pills to the market.
Custer said there are about 8 million obese patients and diabetes medications, but it may benefit about 170 million from the medications.
“To meet this need, we will need other options, including oral small molecules like Orforglipron, which use different production methods and do not need to be used as the sophistication of the supply chain to distribute it to patients,” he said.
Amy Sheer, a professor of medicine at the University of Florida and director of the Obesity Medicine Scholarship Program, said she hopes the pill is cheaper than existing injections, largely because of the high cost of the equipment they use. She said lower prices could help remove barriers for patients and could make insurers more willing to cover the drug.
Many insurance companies still do not cover obesity GLP-1. Wegovy and other drugs are priced at about $1,000 before insurance.
Detailed test results
According to the trial results, the highest dose of Eli Lilly pills helped more than 59% of patients lose at least 10% of their body weight and more than 39% of patients lose at least 15% of their body weight.
Almandos said the proportion of people who get “big weight loss” is “very impressive for verbal agents,” adding that many people “often ignore the proportion of people who achieve these high weight loss categories” and usually focus closely on average weight loss.
Orforglipron also helps alleviate cardiovascular risk factors.
However, according to some analysts’ estimates, data on tolerance to some patients in the trials.
About 10.3% of patients taking the highest dose of the pill (36 mg) stopped treatment due to side effects, compared with about 2.6% of patients with placebo. These side effects are mainly gastrointestinal tract, such as nausea and vomiting, with mild to moderate severity. It is estimated that 24% of people taking the highest dose experienced vomiting, while 33.7% and 23.1% had nausea and diarrhea, respectively.
BMO capital market analyst Evan Seigerman said before the data that he expects the highest dose of pills to be less than 10% due to lower rates of side effects and vomiting, nausea and diarrhea.
Dr. Caroline Apovian, co-director of the Weight Management and Health Center at Brigham and Women’s Hospital, said that compared with existing GLP-1 on the market, the pills were stopped due to side effects. The rate of discontinuation due to the side effects of weekly obesity injections by late-stage trials on Wegovy and Eli Lilly is About 7% Or less.
She noted that for any reason nearly a quarter of patients had discontinued treatment in the pills, warning not to ease Orforglipron’s enthusiasm because we got all this excitement and then the pills would come out and then no one could take it. ”
It is not clear why these patients had interrupted the pills in addition to side effects.
But the University of Florida says she doesn’t think the doctor’s termination rate or side effects when prescribing medication will be a determinant for the doctor.
She believes oral choices can actually make more doctors more comfortable prescribing GLP-1 to patients. Sheer added that some doctors are currently hesitant because they “may not know how to tell patients how to use them.”
Armandos said prescription decisions will depend on the patient’s specific needs and preferences as well as accessibility and affordability. Injectable GLP-1 may be preferred for patients with higher weight loss levels or with significant cardiologic complications or those with health problems caused by cardiovascular and metabolic diseases.
However, for those who “prioritize simplicity or convenience or face these logistical challenges when it comes to injections,” oral GLP-1 may be the best fit.
The detailed results of the trial will be presented in September at the European Medical Conference and published in a peer-reviewed journal. Results of the Phase 3 trial on the pill will be shared later this year, including a study on adults who are obese or overweight and have type 2 diabetes.
Wegovy, Eli Lilly’s Pill, Orforglipron and Novo Nordisk’s diabetes pill, Rybelsus, all target a gut hormone called GLP-1 to promote weight loss and regulate blood sugar. However, unlike other drugs, Eli Lilly’s pills are not peptide drugs. This means it is more easily absorbed in the body and does not require dietary restrictions like Rybelsus does.
Yili Lilly is currently about three years ahead of other pharmaceutical manufacturers to develop pills Pfizer,,,,, AstraZeneca,,,,, Luo’s,,,,, Structural Therapy and Viking TherapyGuggenheim analyst Seamus Fernandez previously CNBC.
Some analysts expect the GLP-1 market to be worth more than $150 billion per year by the early 2030s. Fernandez said the value of oral GLP-1 could be worth $50 billion.
-CNBC’s Angelica Peebles contributed to this report.
