BELGIUM – The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Sanofi’s Sarclisa (isatuximab) in combination with Velcade, Revlimid, and dexamethasone (VRd).
This therapy is intended for newly diagnosed multiple myeloma (MM) patients who are ineligible for autologous stem cell transplants.
This recommendation stems from the results of the global Phase III IMROZ trial, which demonstrated that adding Sarclisa to the VRd regimen improved progression-free survival compared to VRd alone.
Sarclisa has been approved in over 50 countries for specific adult patients with relapsed or refractory MM, leveraging its mechanisms, including apoptosis induction and immunomodulatory activity.
The CHMP found its safety profile, when combined with VRd, consistent with prior research, with no new safety concerns.
Dietmar Berger, Sanofi’s global head of development and chief medical officer, stated: “The positive CHMP opinion is an important step forward for people with transplant-ineligible newly diagnosed multiple myeloma for whom effective front-line therapy may improve long-term outcomes.
“If approved, this Sarclisa-based combination could establish a new standard-of-care treatment approach for patients in the EU, helping to address a critical care gap in multiple myeloma treatment, and reinforcing Sarclisa’s potential as the anti-CD38 therapy of choice.”
Expanding access and advancing research
The U.S. Food and Drug Administration (FDA) granted Sarclisa orphan drug exclusivity for this indication in September 2024.
Sanofi is actively exploring additional clinical applications for Sarclisa, conducting a range of Phase II and III trials.
The company is also testing a subcutaneous administration method in clinical trials. However, regulatory authorities have yet to evaluate Sarclisa’s safety and efficacy for uses beyond its approved indications.
FDA reviews Dupixent for Chronic Spontaneous Urticaria
The FDA has accepted the resubmission of a supplemental biologics license application (sBLA) for Dupixent (dupilumab) by Regeneron Pharmaceuticals and Sanofi.
The application seeks approval to treat patients aged 12 and older with chronic spontaneous urticaria (CSU) that does not respond to H1 antihistamines.
If approved, Dupixent would be the first targeted therapy for CSU in over a decade. Dietmar Berger commented on its potential impact: “This treatment could transform care for more than 300,000 U.S. patients suffering from inadequately controlled CSU.”
Robust Clinical Evidence Supports Application
The resubmission includes new data from the LIBERTY-CUPID Phase III program. Study C, conducted in biologic-naïve patients, confirmed earlier findings that Dupixent significantly reduced itching and hives.
Japan was the first country to approve Dupixent for CSU earlier this year. The FDA is expected to make its decision by April 18, 2025.
Sanofi and Regeneron stocks have responded positively to these developments. As of the last trading session, Regeneron closed at US $782.51, while Sanofi saw a premarket gain of 1.09%, trading at US $48.34.
