Novo Nordisk, Inc.

iStock, Ahmad Darmansyah The FDA accepted Novo Nordisk’s NDA for an oral formulation of Wegovy. The agency is expected to release its verdict on the drug in the fourth quarter of this year. The FDA on Friday accepted Novo Nordisk ’s New Drug Application for an oral formulation of its widely popular obesity drug Wegovy for chronic weight management, bringing the Danish drugmaker one step closer to winning the first regulatory approval for a GLP-1 pill specifically for weight-loss. Novo did not provide a specific target action date for oral Wegovy, only announcing in its news release that the FDA’s verdict is expected in the fourth quarter. If approved, Wegovy’s pill form will carry a 25-mg dose of the drug, scheduled for once-daily dosing in adults who are overweight or obese and who have at least one comorbid condition. Supporting Wegovy’s oral bid are results from the Phase III OASIS 4 study. A November 2024 readout showed that daily oral Wegovy could match the weekly injectable in lowering bodyweight, Healio reported at the time. Novo did not provide additional data comparing oral versus injectable Wegovy in its Friday release. OASIS 4 also found that oral Wegovy significantly outperformed placebo, cutting an average of 13.6% of participants’ weight, as opposed to 2.4% in the control group. The oral drug also had a safety pro with its injectable formulation. Wegovy can cause adverse effects like nausea, diarrhea, constipation and abdominal pain. Last month, a Novo spokesperson confirmed to BioSpace that the pharma had filed for approval for oral Wegovy. The spokesperson also clarified that Novo already has an oral GLP-1 on the market. Rybelsus, an early brand of semaglutide, was given the FDA’s go-ahead in September 2019 for oral dosing. But instead of being indicated for chronic weight management, Rybelsus is approved to treat type 2 diabetes. Novo is locked in a close race with Eli Lilly to bring the first weight-loss pill to the market. Last month, Lilly announced that orforglipron, an orally available GLP-1 treatment, significantly lowered blood glucose levels in patients with type 2 diabetes. Analysts at the time were bullish about these findings, with BMO Capital Markets noting that orforglipron achieved “injectable like efficacy.” Study participants also lost 7.9% body weight after orforglipron treatment, as compared with 1.6% in placebo. A few days after the late-stage win, Lilly CEO David Ricks told Fox Business that while the study was primarily in diabetes, the pharma’s first drug application for orforglipron will be for chronic weight management later this year. Lilly will subsequently approval for type 2 diabetes in 2026. The company also promised to manufacture the drug in the U.S.

In essence, a formulary change is likely to boost access to Novo Nordisk's Wegovy in the U.S., though potentially at the expense of that for Eli Lilly’s Zepbound. Just as Eli Lilly appeared to be gaining an edge over its metabolic medicine rival Novo Nordisk in the U.S. obesity market, Novo has locked in a new formulary access deal that could give its star weight loss drug Wegovy a major advantage over its Lilly counterpart.Starting July 1, Wegovy will become the preferred GLP-1 for obesity treatment on CVS Caremark’s largest commercial template formularies, Novo said Thursday. CVS Caremark, which forms the eponymous pharmacy chain’s drug benefits unit, is the largest pharmacy benefit manager in the U.S., as Novo pointed out.The move will knock Lilly’s dual GIP/GLP-1 receptor agonist for obesity, Zepbound, off CVS Caremark’s present formulary (PDF), with a CVS spokesperson confirming in a statement to Bloomberg News that Lilly’s drug “will be excluded” in health plans using CVS’ standard list of covered drugs.People on those plans who are already using Zepbound will be able to pivot over to Wegovy or potentially receive exemptions for a medical need on a case-by-case basis, the spokesperson added.In essence, the formulary change is likely to boost access to Wegovy in the U.S., though potentially at the expense of that for Lilly’s Zepbound. The Caremark formulary implicated in the deal covers “tens of millions of lives,” Prem Shah, executive vice president and group president of CVS Health, said on the company’s earnings call Thursday. For Novo, the CVS deal is part of an ongoing effort to improve access to Wegovy, which has proved elusive for patients in recent years thanks to supply constraints, a steep price tag and insurer reticence to cover the wildly popular GLP-1 drug class.“As the leader in obesity care for more than a decade, it is our responsibility to continue to work with others across the U.S. healthcare system to find innovative opportunities to meet the needs of these patients and connect them with authentic, FDA-approved Wegovy in a convenient and affordable way,” Dave Moore, Novo’s EVP of U.S. operations, said in a statement.Back in early March, the drugmaker launched the NovoCare Pharmacy, which offers direct home shipping of Wegovy for cash-paying patients at a reduced cost of $499 per month. That price covers all five of the med’s dosage strengths and is significantly cheaper than the current list price of $1,349 per package.More recently, the company updated the savings plan so that certain patients who pay out of pocket can get the $499-per-month price at local brick-and-mortar pharmacies, too.Under the new CVS deal, Novo is permitting the pharmacy giant to sell Wegovy for $499 to cash-paying customers at its more than 9,000 locations around the U.S., Bloomberg noted in its report.The deal is undoubtedly a blow for Novo’s rival Eli Lilly, though the company’s CEO, David Ricks, said he was “not surprised this kind of thing was announced,” when asked about the CVS formulary agreement during Lilly’s first-quarter earnings call this week.Ricks admitted that the private pay market is important and that he’d like Lilly to grow in that area, while also fostering more choice for those who pay out of pocket. He stressed that his company is “not interested at all in one-of-one deals of reducing access and choice for doctors and patients.”On the affordability front, Lilly did something similar to Novo’s out-of-pocket discount for Wegovy in late February when it announced that it would cut the prices of its 2.5-mg single-dose Zepbound vials to $349 per month and its 5-mg vials to $499.At the time, Lilly’s cardiometabolic health president, Patrik Jonsson, said the company was charting the move because "insurance and federal programs do not systematically cover people living with obesity for medical care" in the U.S. Meanwhile, CVS wasn’t the only one at the Wegovy dealmaking table with Novo this week.Tuesday, Novo announced that it’s teaming up with a trio of telehealth companies—Hims & Hers, LifeMD and Ro—to help patients access branded Wegovy through its NovoCare online pharmacy.Under the deals, Hims & Hers is offering a $599 bundled monthly subscription that includes access to 24/7 care, ongoing clinical support and nutrition guidance as well as prescriptions for all doses of Wegovy. Meanwhile, Ro and LifeMD will both offer Wegovy at $499 per month, alongside additional weight management programs.The accord is notable given how recently Novo and Hims & Hers sparred over the latter company’s practice of selling compounded versions of semaglutide—Wegovy’s active ingredient—while the medication was in shortage. 

Enhanced tax incentives or an extension of the U.S. Tax Cuts and Jobs Act make “better tools” to spur U.S. growth than import tariffs do, Eli Lilly CEO Dave Ricks said. As multiple large drugmakers look to navigate trade turbulence by pumping billions of dollars into their U.S. operations, a growing number of biopharma leaders are speaking out against the Trump administration’s tariff agenda.Take Eli Lilly helmsman Dave Ricks, for example. Despite the Indianapolis pharma making a $27 billion U.S. production pledge in late February, Ricks took his company’s first-quarter earnings call Thursday to argue against trade levies as the best policy for supporting local industry. “We support the U.S. government’s goals to increase domestic investment,” the CEO said on the call. “However, we don’t believe tariffs are the right mechanism.”Rather, “enhanced” tax incentives—or an extension of the Tax Cuts and Jobs Act—are “better tools” to spur U.S. growth, Ricks contended. The President Donald Trump-led Republican Party ushered in the Tax Cuts and Jobs Act in 2017, slashing the U.S. corporate tax rate from 35% to 21%, among many other measures. Now, as the threat of sector-specific tariffs on pharmaceuticals dominates the industry’s attention, multiple biopharma leaders have been advocating for tax reform—rather than trade duties—as a preferable route to bolster U.S. manufacturing and investments.Notably, Johnson & Johnson CEO Joaquin Duato and AbbVie Chief Financial Officer Scott Reents also used their company’s recent earnings calls to argue in favor of more competitive tax policies—and caution against the potential harm tariffs may inflict.A big part of Trump’s goal with his tariffs—both imposed and threatened—is to spur a return to U.S.-based manufacturing. On that front, Lilly, like many others in the pharma industry, appears willing to play ball.In late February, the drugmaker said it would invest $27 billion and start construction this year on four new U.S. manufacturing facilities. Once completed, the effort should equip Lilly to make all its medicines for the U.S. market in the U.S., Ricks said on Thursday’s call.In summarizing his thoughts, the CEO urged the second Trump administration to “negotiate deals with key trading partners as soon as possible, then level the playing field for American exporters like Lilly and remove harmful tariffs and non-tariff market access barriers in the developed economies.”The CEO’s comments came as Lilly posted a 45% year-over-year revenue increase to $12.73 billion in 2025’s first quarter. Unsurprisingly, much of that growth can be attributed to the Indianapolis drugmaker's star GIP/GLP-1 blockbusters Mounjaro and Zepbound, the company explained in an earnings release.Mounjaro, approved in Type 2 diabetes, raked in $3.8 billion for the period, growing a staggering 113% over the $1.8 billion it brought home during 2024’s first quarter. Mounjaro’s obesity counterpart Zepbound generated $2.3 billion in the quarter, compared with $517 million during the first three months of the previous year. The FDA approved Zepbound in November 2023.Lilly also noted that its breast cancer med Verzenio grew sales 10% to $1.2 billion in the first quarter, while the company’s SGLT2 inhibitor Jardiance benefited from a one-off $370 million gain after Lilly and Boehringer Ingelheim tweaked their commercialization pact for the drug.Still, even drugs like Mounjaro and Zepbound can stumble.Following talks with the FDA, Lilly has withdrawn its application for tirzepatide—the molecule underpinning both Mounjaro and Zepbound—in heart failure with preserved ejection fraction (HFpEF), the company’s chief scientist, Dan Skovronsky, M.D., Ph.D., said on Lilly’s call.While the company feels the phase 3 data from its Summit trial merit an approval in the indication, the FDA communicated that it would need an additional confirmatory clinical trial to move forward, Skovronsky explained.Last August, Lilly reported data from the Summit study that showed tirzepatide reduced the risk of adverse HF outcomes like hospitalization or cardiovascular death by 38% compared to placebo. The study tested Lilly’s dual GIP/GLP-1 receptor agonist against placebo in 731 patients with HFpEF and obesity.A peptide drug stumbling in the HFpEF indication isn’t unique to Lilly: Last Summer, Novo Nordisk pulled its heart failure application for Wegovy—Zepbound’s chief rival in obesity—and telegraphed plans to resubmit its filing in early 2025.Because Novo’s studies in the indication were “reasonably small,” the FDA wanted to see an increase in number of total cardio events to validate Wegovy’s effect, Novo development chief Martin Holst Lange, M.D., Ph.D., said at the time. Novo subsequently resubmitted its application in January with additional data, a company spokesperson confirmed.  Looking forward at the rest of the year, Lilly is sticking by the 2025 revenue guidance it’s previously communicated. The company currently expects to generate sales between $58 billion and $61 billion for the full year. The company caveated that its financial expectations are based on the “existing trade environment as of May 1, 2025.” The forecast does not account for any policy shifts, including potential pharmaceutical-specific import tariffs, Lilly said.