Daratumumab

Johnson & Johnson (J&J) has announced that its CD38-directed antibody Darzalex (daratumumab) has been recommended by the European Medicines Agency’s human medicines committee to treat smouldering multiple myeloma (SMM), an asymptomatic intermediate disease state of multiple myeloma (MM). The Committee for Medicinal Products for Human Use (CHMP) has recommended that a subcutaneous formulation of the drug be used as a monotherapy to treat SMM in adults who are at high-risk of developing MM. More than 35,000 people in the EU were diagnosed with MM, a currently incurable blood cancer that affects a type of white blood cell called plasma cells, in 2022. SMM accounts for around 15% of all new cases of the disease and is not generally treated until active MM develops. However, recent evidence has suggested that patients at high-risk for progression to active MM could benefit from earlier therapeutic intervention. The European Commission (EC) will now review the CHMP’s positive opinion as it makes a final decision on Darzalex in this indication. If approved, Darzalex would be the first therapy approved in the EU for SMM. The CHMP’s decision, which comes less than a month after a US Food and Drug Administration panel of experts recommended the drug for the same patient population, was supported by positive results from the late-stage AQUILA study in 390 SMM patients at high risk of progression. At a median follow-up of 65.2 months, median progression-free survival (PFS) was not reached in the Darzalex group versus 41.5 months for the active monitoring cohort, with an estimated 60-month PFS rate of 63.1% versus 40.8%, respectively. Ester in’t Groen, EMEA therapeutic area head haematology, J&J Innovative Medicine, said: “Early disease intervention with [Darzalex] has the potential to reduce the risk of progression to active MM or death by 51% for patients with high-risk disease. “Pending EC approval, patients and physicians will have an option to treat high-risk SMM, with the aim to intercept this complex blood cancer before it develops into active disease and importantly, before end-organ damage occurs.”

iStock, Yutthana Gaetgeaw Eli Lilly’s tirzepatide is expected to be worth $62 billion annually by 2030, according to Evaluate. That valuation would be three times larger than what AbbVie’s blockbuster Humira ever achieved. Total prescription drug sales are expected to grow to $1.75 trillion by 2030, at which point GLP-1 therapies will make up 9% of total prescriptions, according to a new report from Evaluate. The weight loss and diabetes mega-blockbusters are expected to grow 20% between 2024 and 2030. “They are in a class of their own,” Evaluate said in the World Preview report , published Tuesday. Eli Lilly’s tirzepatide, marketed as Mounjaro for diabetes and Zepbound for weight loss, is expected to rake in $62 billion a year by 2030, according to Evaluate. That valuation would be three times larger than what AbbVie’s blockbuster Humira—long considered the best-selling drug in the world —achieved. It’s double the 2024 sales of Merck’s Keytruda. The broader category of GLP-1 drugs are “projected to reach hitherto unseen sales peaks,” according to Evaluate. This class of drugs is expected to have five of the top 10 slots on the best-sellers list by 2030 and will be four of the most promising candidates in the pipeline. But Lilly appears to be clearly leading the way. “Lilly’s supremacy in this battle is already apparent,” Evaluate wrote. Mounjaro and Zepbound are expected to be the best- and third-best selling drugs by the end of the decade. Lilly’s main competitor is Novo Nordisk, whose semaglutide is marketed as Wegovy for diabetes and Ozempic for weight loss. Those drugs sit at sixth and fifth, respectively. “First-mover Novo Nordisk lost ground due to its sluggish response to manufacturing shortages of Wegovy (semaglutide), which led to a flood of compounded (pharmacy-mixed) drug,” according to the report. Novo has acknowledged some stumbles, even ousting CEO Lars Fruergaard Jørgensen in May in a surprise move. Evaluate did say that Novo’s pipeline asset CagriSema, which combines semaglutide with an amylin agonist, is the most promising asset in R&D at the moment, with peak sales projections of $80 billion. But the drug has stumbled in the clinic, falling short of expectations and forcing Novo to launch a longer-duration trial to test different dosing. “If it doesn’t improve, CagriSema will only match Zepbound in efficacy, yet is more complex to manufacture,” Evaluate said. The Rest of the Best Immuno-inflammatory drugs will also continue to lead, with AbbVie’s Skyrizi and Sanofi/Regeneron’s Dupixent in the forefront and on track to make over $25 billion each in 2030. Oncology, too, will have a story to tell in 2030, with Johnson & Johnson’s Genmab-partnered blood cancer drug Darzalex meeting Merck’s falling star Keytruda as its patent expires in 2028 . The current best-selling immuno-oncology drug will fall to seventh place by 2030. “Keytruda’s 2028 expiry puts Merck at the top of the most exposed companies to patent-related sales losses over the rest of the decade—and is the only top ten drug with negative growth,” Evaluate wrote. But Merck is hoping to patch some of the holes in its Keytruda losses with a subcutaneous formulation that Evaluate named as one of the most valuable pipeline drugs by net present value. “It’s a shining case study in life-cycle management,” the analysis firm said, and one that the forthcoming GLP-1 combos and formulations may be able to copy as pipeline assets like oral GLP-1 orforglipron and triple-G agonist retatrutide are expected to take the market by storm . Pfizer has taken one of the biggest tumbles on Evaluate’s rankings, falling from the number one slot in the pandemic years to last place in the list of top 10 companies with the most drug sales expected in 2030. Novartis is also expected to be stuck in the bottom half as it lacks a standout blockbuster. Sanofi, on the other hand, is the “most impressive” non-GLP-1 company rising up the list, according to Evaluate. The French pharma is rising thanks to Dupixent, which is expected to grow by 10%.