Novartis has netted a pair of regulatory wins, winning European approval for an oral therapy in chronic spontaneous urticaria (CSU) and, separately, receiving World Health Organization (WHO) prequalification for its antimalarial medication.
The European Commission (EC) has approved Novartis’ Rhapsido (remibrutinib) for certain CSU patients, becoming the first oral treatment for the skin disease.
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Rhapsido is approved for adult CSU patients in Europe who have not responded to H1-antihistamines, a first-line treatment for the disease. The pill, which is taken twice daily, is a BTK inhibitor that works by blocking pathways involved in the release of histamines.
CSU is a condition that causes itchy and painful hives lasting six weeks or more without an external trigger. It is primarily caused by skin cells releasing histamine and other inflammatory mediators.
Data across 926 CSU patients from the Phase III REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) trials demonstrated that Novartis’ drug significantly improved itch and hive symptoms. The drug’s safety profile also means no lab monitoring is required. The most common adverse events (AEs) in the studies were nasal congestion, sore throat, and runny nose, amongst others.
Marketing authorisation for Rhapsido in Europe follows a similar decision in the US last year – the US Food and Drug Administration (FDA) approved the pill for the same patient population in September 2025.
Novartis’ entry into the CSU market places the Swiss drugmaker in direct competition with established anti-inflammatory drugs, including Sanofi and Regeneron’s Dupixent (dupilumab) and Roche’s Xolair (omalizumab). Rhapsido’s oral route of administration could provide a foothold for Novartis to gain market share from the blockbuster therapies, which are both given via injections.
Analysis by GlobalData’s Pharma Intelligence Centre forecasts global sales for Rhapsido in CSU will reach $2.6bn by 2032.
GlobalData is the parent company of Pharmaceutical Technology.
The label for Rhapsido could expand in the future. Novartis is evaluating the drug as a treatment for multiple sclerosis (MS), with a Phase III trial (NCT05156281) currently ongoing. Development in other immune-mediated conditions, such as chronic inducible urticaria, food allergy and hidradenitis suppurativa (HS), is also underway.
WHO prequalifies Novartis’ antimalarial
The Rhapsido approval comes just days after Novartis received WHO prequalification for its malaria treatment, Coartem Baby (artemether-lumefantrine), the first antimalarial specifically developed for newborns and infants weighing 2kg to 5kg.
This step enables wider public sector procurement, supporting greater access in malaria-endemic regions.
Known as Riamet Baby in some areas, Coartem Baby was developed in partnership with Medicines for Malaria Venture (MMV).
WHO’s prequalification process evaluates the safety, efficacy, and quality of treatments for major diseases, including malaria, HIV/AIDS and tuberculosis.
Outputs from this process, such as lists of prequalified products, inform public sector purchasing and funding decisions by the United Nations and related agencies.
Novartis stated that it will supply the treatment on a primarily not-for-profit basis in malaria-affected areas.
Novartis global health president Dr Lutz Hegemann said: “This decision takes us one step closer to ensuring that the tiniest babies have access to the first antimalarial designed specifically for them.
“We have already introduced the treatment in Ghana and are pleased to now be going further together with our partners to reach even more of the smallest malaria patients.”
Coartem Baby was developed by Novartis and MMV as part of the PAMAfrica consortium, which received funding from the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency.
Since 2021, Novartis has invested over $500m in global health R&D, including advances in new compounds for resistant malaria. The company has delivered more than 1.1 billion Coartem treatment courses since 1999.
Last month, Novartis signed an agreement to acquire biotech business Excellergy, which specialises in the development of next-generation anti-immunoglobulin e (IgE) therapies for up to $2bn in upfront and milestone payments.
