EMA recommends six new medicines, including an oral treatment and a cancer therapy

The Committee for Medicinal Products for Human Use of the European Medicines Agency, the Chmp, adopted positive opinions for six new medicines and for the extension of indications of five other drugs already authorised in the European Union. The news currently comes from a single source, traceable to the Chmp statement picked up by several outlets; no further independent confirmation of the assessment details is available.

Among the recommended medicines is Rasonque, active substance daraxonrasib, an oral treatment for metastatic pancreatic adenocarcinoma. According to data assessed by the Chmp, the drug is associated with a median overall survival of 12.4 months, compared with 6.7 months recorded with chemotherapy alone. The sample size and the clinical trial phase on which this comparison is based were not disclosed in the available material.

The committee also recommended Foundayo, active substance orforglipron, an oral Glp-1 agonist developed by Eli Lilly, for weight management and for type 2 diabetes in adults. The drug had already been approved in the United States in April, a precedent concerning a different regulatory agency and a different regulatory framework from the European one.

Among the other recommendations is Yuviwel, active substance navepegritide, indicated for the treatment of achondroplasia in children.

In all cases, these are positive opinions from the EMA’s scientific committee, a step that precedes the possible final marketing authorisation in the European Union, which falls under the competence of the European Commission. The survival data and therapeutic indications reported are those assessed by the committee itself, with no further details available on the design of the underlying studies or on any conflicts of interest declared by the manufacturers.

The complete list of opinions, including the five indication extensions for already authorised drugs, is published in the official Chmp documents, which remain the primary reference for anyone wishing to verify the technical details of the individual assessments.