The First $100 Billion Drug

An obesity medication is reportedly poised to shatter the record for pharmaceutical sales volume

BY ED MCKINLEY

A prescription drug that combats obesity is expected to become the biggest-grossing pharmaceutical in history, ringing up five times the sales volume of its nearest competitor, an industry authority predicts.

“With modest patient penetration, we could see tirzepatide generating more than $100 billion in sales annually” for drug manufacturer Eli Lilly & Co. (LLY), says Bank of America analyst Geoffery Meacham.

That would dwarf the one-year record of $21 billion in sales that the anti-inflammatory drug Humira posted in 2021 for its maker, AbbVie (ABBV). But a tirzepatide juggernaut seems likely, partly because the medication could prove effective in the treatment of a number of maladies.

Lately, tirzepatide has been generating buzz and capturing headlines for its ability to address obesity. It’s expected to earn U.S. Food and Drug Administration (FDA) fast-track approval this summer for treating that condition.

Yet the drug’s not as new as its pending certification might make it seem. Lilly received a patent for it in 2016, and it won FDA approval a year ago as a treatment for Type 2 diabetes.

Plus, a string of additional FDA approvals may extend far into the future and contribute to its projected record-breaking sales volume. Someday soon, the drug may earn certification for liver problems, sleep apnea, kidney disease and heart failure.

Let’s look first at tirzepatide for weight loss, the application of the drug that was lighting up the internet as Luckbox went to press.

TREATING OBESITY

Tests show tirzepatide affects two parts of the brain where hunger resides. Other weight-loss drugs that have recently won FDA approval can influence just one part of the brain, multiple sources say.

Tirzepatide works by curbing appetite, according to Lilly, the Indianapolis-based industry giant that developed the medication. The drug makes recipients feel full

sooner, encouraging them to eat less and thus lose weight. It also improves control of blood sugar, a Lilly report says.

In a clinical trial of the drug, participants lost up to 22.5% of their body weight or 52 pounds, the maker says. Viewed another way, 63% of the test subjects shed at least 20% of their weight. Average weight loss was 16% or 35 pounds in a 72-week trial that included 2,539 participants, and 89% lost at least 5%.

An overweight nation may welcome those results. The United States ranks near the top in obesity among developed countries. About 42% of American adults suffer from the disease, up from 10% in the 1950s, according to the Centers for Disease Control and Prevention.

Obesity becomes more prevalent as higher income enables the population to consume high-calorie foods and lead more sedentary lives. At the same time, doctors consider the condition a disease that results from the brain’s survival instinct.

Together, health problems related to obesity and less severe but still significant weight problems claim the lives of about 325,000 Americans annually, says the National Institutes of Health (NIH). That makes being overweight the No. 2 cause of preventable death in the United States, second only to using tobacco, the NIH says.

Although tirzepatide could forestall some of those deaths and ease much of the associated suffering, the drug still doesn’t qualify as a panacea.

THE TIRZEPATIDE DOWNSIDE

Like so many pharmaceuticals, tirzepatide can produce unwanted or even dangerous physical reactions.

Common side effects—the ones patients most often experience—include indigestion, constipation, decreased appetite, nausea, vomiting, diarrhea and intense abdominal pain, according to WebMD, a site for the healthcare profession.

Infrequent side effects listed on the website—which tend to be more severe but more unusual than common side effects—are gas, burping, abdominal bloating, skin reactions at the site of the injection and gastroesophageal reflux disease.

Rare yet severe side effects include gallstones, hypersensitivity and decreased kidney function.

The drawbacks don’t end with undesirable physical issues. Tirzepatide can also come with what some would consider a prohibitively high price tag.

COSTLY TREATMENT

Four weekly doses of tirzepatide cost $974.33, which adds up to around $12,666 annually, the Medscape website says.

Help with those bills may or may not be forthcoming.

Some insurance companies have declared weight loss a matter of vanity and may not cover drugs that address the disease, Pharmacy Times reports.

Medicare covers some approaches to dealing with obesity, like behavioral therapy, but doesn’t pick up the bill for anti-obesity drugs, according to the National Council on Aging.

Medicaid pays for pharmaceuticals that target obesity under the programs in some states, but not others, says the Journal of the American Medical Association.

Some patients might need to take the medicine as long as they live, so for them the cost would never cease.

And even after raising the funds to finance tirzepatide, some patients may find it daunting to inject the drug themselves at home.

Some experience such intense anxiety at the prospect that they forego their medication, Amber Specialty Pharmacy notes on its website.

IN A 72-WEEK CLINICAL TRIAL OF TIRZEPATIDE, 63% OF THE 2,539 TEST SUBJECTS SHED AT LEAST 20% OF THEIR WEIGHT. AVERAGE WEIGHT LOSS WAS 16% OR 35 POUNDS.

What’s more, taking a weight-loss medication for an indefinite period could distract patients from the need to control their weight by exercising and eating properly, some doctors say.

Meanwhile, some consumers have already embarked upon a tirzepatide regimen for weight loss, even though the FDA hasn’t approved it for that.

That’s because many doctors are already prescribing it off-label for shedding pounds, The Washington Post reports. The term “off-label” refers to the fairly common practice of ordering a medication that’s FDA-approved for some other ailment. (See p. 28.)

THE SPECTER OF SCARCITY

Prescribing tirzepatide for losing weight seems certain to be a factor in a shortage of the drug for diabetes patients. It’s marketed to fight diabetes under the brand name Mounjaro, and the FDA has added it to the lists of pharmaceuticals in short supply.

Moreover, the demand for tirzepatide could become even greater if it wins the FDA’s blessing for treating a laundry list of series conditions—something Bank of America analyst Geoff Meacham says he fully expects.

So, it becomes a matter of ramping up production to fill all the orders along the way to becoming the first $100 billion pharmaceutical.

Critics Question Alzheimer’s Research

Pharmaceutical companies are inundating the market with drugs meant to slow the progress of memory-robbing Alzheimer’s disease, but skeptics insist they’re taking the wrong approach.

Most researchers study the effects of prescription drugs on brain-clogging amyloid plaque, says Joanne Silberner, a National Public Radio correspondent and veteran of the medical beat. She claims they’re squandering time and resources.

The problem is some of the nation’s 6.5 million Alzheimer’s victims don’t have a buildup of that plaque, and some people who have the plaque aren’t subject to Alzheimer’s symptoms, Silberner says in an article on The Free Press website.

Yet anyone who raises doubts about focusing on plaque is quickly shut down and marginalized, she says in the story. They’re repudiated despite what they view as decades of painfully slow progress against Alzheimer’s.

One of the Alzheimer drugs generating publicity these days goes by the generic name lecanemab and is marketed as Leqembi by two companies, Tokyobased Eisai (ESALY) and Biogen (BIIB), which has headquarters in Cambridge, Massachusetts.

In an 18-month test of 1,795 people in the early stages of Alzheimers, interviews and brain scans showed Leqembi slowed cognitive decline by 27%, the manufacturers say. That’s not enough for the skeptics, but it satisfied the U.S. Food and Drug Administration, which granted the drug accelerated approval in January.

Leqembi could post $6.5 billion in sales by 2030, according to a Bank of America report. The cost of a dose every two weeks comes to $26,500 a year, Eisai officials say.