Three years ago, drugmakers and laboratories around the world responded to the pandemic with Covid-19 vaccines. Now that the urgency has faded, they’re collectively turning attention to an older pandemic: obesity.
Companies including Eli Lilly & Co. and Pfizer Inc. are tailgating Novo Nordisk A/S, the first mover into the market with its highly effective Wegovy injection that mimics a weight-related hormone called GLP-1. Amgen Inc. was also among companies presenting at the JPMorgan Healthcare Conference this week with a potential obesity entrant. The companies are aiming for the market with versions that either melt off more pounds, have less frequent dosing or don’t require injection.
The search for a safe, effective slimming drug been long and torturous. Prescriptions for the combination of fenfluramine and phentermine, known popularly as fen-phen, soared to more than 18 million in 1996 after the success of a small study, then crashed after it was linked to heart disease and deaths. Now, drugmakers say, better science and promising weight-loss results from the new class of repurposed diabetes drugs are spurring a roaring comeback for medicines to treat obesity.
“This is the beginning of a whole new therapeutic area,” Lilly Chief Scientific Officer Daniel Skovronsky said in an interview at the annual health-care confab. One of Novo’s chief competitors in insulin and other diabetes treatments, Lilly is completing a second late-stage trial of its injectable drug tirzepatide. Another trial showed last year that the drug helped patients lose more than 20% of their body weight.
Hormone mimic
GLP-1 is an incretin, a hormone secreted from the gastrointestinal tract that tells the body that food has been eaten. For years, Lilly and Novo have been developing drugs targeting the receptors for incretins, first for diabetes and now for obesity.
By mimicking this natural biology, the new drugs appear to make people feel less hungry, Lilly’s Skovronsky said. They also help reduce blood glucose levels, which can help many people with both obesity and diabetes.
There are several types of incretins, and next-generation drugs are aiming at multiple targets in hopes of helping patients shed more pounds. Lilly’s tirzepatide, for example, mimics a second incretin along with GLP-1, as does Amgen’s experimental AMG 133.
With nearly three in four U.S. adults considered overweight or obese, Wall Street has big expectations for the drug class. The overall obesity market will reach about $30 billion by 2030, according to Cowen Inc. analysts, with Lilly’s tirzepatide seeing more than $11 billion of those sales. That would overtake the more-than $7 billion in sales estimated for Novo’s Wegovy.
The drugs’ high cost — Wegovy costs $1,350 a month — and lack of insurance coverage for obesity medicines present a key barrier to uptake. “Outdated notions and persisting misconceptions” about the nature and seriousness of obesity stand in the way of effective weight-loss medications’ use, the health nonprofit ECRI said this week. The group is appealing to insurers and politicians to change policies on paying for FDA-approved weight loss medications, Marcus Schabacker, the group’s president and CEO, said in an interview.
The drug class “seems to be working, it seems to be safe, it seems to be effective,” he said.
Although it’s in early-stage trials, Amgen’s AMG 133 is already the focus of investor interest. Patients on the highest dose saw an average loss of 14.5% of their weight after 12 weeks of treatment in an early stage trial, according to results released in December. Although other companies are closer to the market, Amgen’s is still likely to be useful, said David Reese, the drugmaker’s executive vice president of research and development.
“It’s an area that’s obviously exploding right now,” he said in an interview. “It’s becoming a field unto itself.”
Pfizer is also testing two drugs that hit the GLP-1 pathway. While Wegovy is injectable, Pfizer’s drugs can taken as a pill, which the company is betting will prove to be a crucial advantage.
“GLP-1, clearly everybody’s excited about that,” CEO Albert Bourla said in a Jan. 9 fireside chat at the San Francisco conference. “This is a market that will grow to $90 billion altogether, and we are very confident on that given the current size of the market and the current growth rates.”
Off-label use
Bourla added that Pfizer could capture about $10 billion of that market. A spokesperson for Pfizer said the $90 billion figure referred to the combined obesity and diabetes markets for the GLP-1 class of drugs.
Novo is also developing CagriSema, a combination of Wegovy’s main ingredient, called semaglutide, and another drug that targets an eating hormone. And it’s developing a pill version of semaglutide.
Lilly’s tirzepatide is on the market for diabetes under the brand name Mounjaro. While it hasn’t been approved for obesity, some doctors are already recommending it for weight loss. Doctors are permitted to prescribe drugs for unapproved uses, a practice called off-label prescribing. Demand for Mounjaro and Ozempic, another GLP-1 drug from Novo, has already led to shortages.
Lilly has started a rolling submission to the Food and Drug Administration that will allow it to very quickly submit the new data to the FDA around mid-year, assuming the second final-stage trial succeeds, Skovronsky said. Depending on when and what regulators decide, the drug could be on the market for obesity as early as the year’s end, he said.
The drugmaker is working to make sure it has enough tirzepatide on hand so it doesn’t repeat the supply issues that afflicted Novo. It’s also testing the drug in obesity-linked conditions such as sleep apnea and heart failure, to see if patients benefit.
“We are adding new factories and making it as quickly as we can,” Skovronsky said. “The potential here is large.”
