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MS Updates from the European Medicines Agency

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ECTRIMS shares three key updates from the European Medicines Agency (EMA) related to neuroimmune-mediated conditions:

1. The Committee for Medicinal Products for Human Use (CMPH) has issued a positive opinion of Uplizna (Inebilizumab) for the treatment of adults with AQP4-IgG seropositive NMOSD and of Enspryng (Satralizumab) for the treatment of adolescents and adults with AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD).

These new products join Soliris (Eculizumab) for the treatment of AQP4-IgG seropositive patients. With these two new products, the therapeutic armamentarium for the treatment of AQP4-IgG seropositive NMOSD patients has substantially improved and will help to define a “new natural history” for affected patients. Unfortunately, the treatment of AQP4-IgG seronegative NMOSD patients remains an unmet need in the field.

2. An extension of indication for the treatment of children with RRMS > 10 years has been issued for Aubagio, which the EMA hopes will help in the management of paediatric-onset multiple sclerosis.

In this application, EMA officials highlight a relevant regulatory aspect: efficacy in the paediatric population with RRMS could have never been demonstrated based only on the results from the pivotal trial study aimed to support the paediatric indication as this pivotal trial failed its primary endpoint. Fortunately, other arguments/data were considered during the evaluation, including efficacy results from MRI data in children. That efficacy has already been demonstrated in adult patients with RRMS and, based on shared biology, extrapolation to paediatric patients. Re-establishing efficacy on its own was not considered necessary. Thus, EMA considered the totality of the data for this application. Further details can be found on the European Public Assessment Report (Aubagio).

3. A positive CMPH opinion for Vumerity (Diroximel Fumarate) in MS treatment was issued in November 2021.

Vumerity has exactly the same indication as Tecfidera. In fact, both medical products share the same active moiety: mono-methyl fumarate. Thus, the efficacy and safety profiles of Vumerity are expected to be in line with the ones of Tecfidera. The CMPH concluded that the claim for additional benefit of improved GI tolerability was not robustly demonstrated for Vumerity. A key conclusion highlighted the methodological aspects of the study used for supporting better gastrointestinal tolerability of Diroximel Fumarate comparted to Dimethyl Fumarate. Further details on the rationale for this conclusion may be found in the EPAR Vumerity.