Three novel medicines recommended for approval by EMA/CHMP

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended three novel medicines for approval at its February 2025 meeting. The European Commission is expected to announce a final decision on approval in the coming months.

The committee recommended granting a marketing authorization for Japanese drugmaker Takeda Pharma’s (TYO: 5402) Deqsiga (human normal immunoglobulin), intended for replacement therapy in people with primary or secondary immunodeficiencies and immunomodulation in people with certain autoimmune diseases. Deqsiga is a duplicate of Kiovig (human normal immunoglobulin), which was authorized in the European Union in January 2006.

The CHMP recommended granting a conditional marketing authorization for US biotech Regeneron’s (Nasdaq: REGN) Lynozyfi (linvoseltamab) for the treatment of patients with relapsed and refractory multiple myeloma, a cancer of the bone marrow. The recommendation is specific to those who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.

Krystal Biotech’s Vyjuvek (beremagene geperpavec) received a positive opinion to treat wounds in patients of all ages with dystrophic epidermolysis bullosa, a serious, ultra-rare genetic skin blistering disease caused by mutations in the collagen type VII alpha 1 chain (COL7A1) gene. Vyjuvek is expected to bring substantial therapeutic benefits and improve the quality of life for patients with this skin disorder. This medicine was supported through EMA's PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support for promising medicines with a potential to address unmet medical needs.

Additionally, a generic medicine, Trabectedin Accord (trabectedin), from Accord Healthcare, received a positive opinion for the treatment of advanced soft tissue sarcoma and of relapsed platinum-sensitive ovarian cancer. The drug is a generic version of Johnson (NYSE: JNJ) Yondelis.

Also, following a re-examination, the CHMP confirmed its initial recommendation to refuse the marketing authorization for French drugmaker Orphelia Pharma’s Kizfizo (temozolomide), a medicine intended for the treatment of neuroblastoma, a rare cancer that forms from immature nerve cells. Temozolomide is the active ingredient of Merck & Co’s (NYSE: MRK) Temodar.