Isatuximab-IRFC

Sanofi’s Sarclisa (isatuximab) has been approved by the European Commission (EC) to treat newly diagnosed multiple myeloma (MM). The drug has been authorised for use in combination with bortezomib, lenalidomide and dexamethasone (VRd) as an induction treatment for adults with newly diagnosed MM who are eligible for autologous stem cell transplant. MM is the second most common blood cancer after non-Hodgkin lymphoma, with approximately 46,000 cases of the disease expected to be diagnosed in Europe this year. Sarclisa is designed to bind to the CD38 protein on MM cells and induce distinct anti-tumour activity. The drug is already approved in the EU across three other MM indications, including in combination VRd to treat newly diagnosed MM in adults who are not eligible for autologous stem cell transplant. The EC’s latest decision means that Sarclisa is now approved in the EU across all lines of therapy, regardless of transplant eligibility, and follows a recent recommendation from the European Medicines Agency’s human medicines committee. The new authorisation was based on results from part one of the phase 3 German-speaking Myeloma Multicenter Group (GMMG)-HD7 study, in which Sarclisa-VRd was associated with a statistically significant minimal residual disease (MRD) negativity benefit at the end of the 18-week induction period. There was also a statistically significant and clinically meaningful improvement in progression-free survival in patients treated with Sarclisa-VRd during induction, regardless of the maintenance therapy received, and 53.1% of patients receiving Sarclisa-VRd and 38% in the study’s control arm experienced continued MRD negativity, defined as MRD negativity persisting from post-induction to post-transplant. Commenting on the latest authorisation, Olivier Nataf, global head of oncology at Sanofi, said: “We have been on a mission to accelerate Sarclisa’s clinical development programme with the hope to bring this important medicine to as many people as possible living with MM. “[This] decision represents a prime example of those efforts, and most importantly, paves the way for Sarclisa to potentially become accessible to even more patients in the EU, regardless of transplant eligibility or line of therapy.”

Sanofi has inched up its full-year guidance after another quarter of strong sales for its Regeneron-partnered drug Dupixent, which the French drugmaker said was catapulted by its recent launch in a chronic lung disease. But its earnings per share of €1.59 missed Wall Street analyst expectations of €1.65, Jefferies analysts wrote. While sales were strong, profits took a hit due to higher operating expenses. The company’s shares were down around 2% on the Paris exchange at market open. Dupixent hit €3.8 billion ($4.3 billion) in sales, up 21% from the same time last year. Sanofi now expects full-year 2025 sales to grow in the high single-digit percentage range, compared to a prior range of mid- to high single-digit growth. Its total Q2 sales increased 10% to €9.9 billion ($11.3 billion). “It is really impressive to see that Dupixent keeps on growing even in the first indications like atopic dermatitis and asthma, which were launched eight years ago,” Sanofi CFO François Roger said on an earnings call with the media. He added that “we are very confident in our set target of around €22 billion in 2030.” Dupixent’s patents are set to start expiring in the early to mid-2030s. The immunology drug secured a US label expansion for chronic obstructive pulmonary disease (COPD) in September 2024. It has since been launched for the disease in eight countries. Global Dupixent sales were strong in the quarter, but were “partially offset” by some weakness in China due to the renewal of the country’s national reimbursement drug list. “We do experience regular price decreases [in China], which are more than largely compensated by very significant volume prices, which is exactly the case as far as COPD is concerned,” Roger said. He added that Sanofi’s growth “goes beyond just Dupixent.” Last week, the company’s CD38-targeting drug Sarclisa clinched an EU label expansion for newly-diagnosed multiple myeloma patients who are eligible for autologous stem cell transplant. Sarclisa sales increased 19% to €140 million in the quarter. Sanofi also won a US label expansion in May for its meningitis vaccine MenQuadfi to protect infants as young as 6 weeks old. But the drugmaker has had a bumpier ride on the pipeline side in the first half of the year. In May, its Regeneron-partnered IL-33 antibody itepekimab passed one Phase 3 trial in COPD but flunked a second . Another inflammatory disease candidate, called amlitelimab, failed a Phase 3 study in asthma the month before. The company also previously reported a Phase 2 disappointment for its oral TNF inhibitor, balinatunfib, in psoriasis. “As a science-focused company, we know that setbacks are a part of the R&D process, so it’s a normal situation,” Roger said. “Our pipeline is diverse, both in terms of acquisition and our own development, which means that we are not exposed to one single asset at the end.” Meanwhile, Roger also said that Sanofi is “committed” to working with the Trump administration to lower “prices for patients at the pharmacy counter.” But he added that “real impact will come from fixing inefficiencies” and “price controls are not the right solution for patients or science.” The CFO said that the company is also considering direct-to-patient sales in the US as a way of improving drug affordability. His comments echo those of AstraZeneca CEO Pascal Soriot and Roche CEO Thomas Schinecker .