EMA Recommends Five Medicines for Approval

The European Medicines Agency’s (EMA’s) human medicines committee (CHMP) recommended five medicines for approval at the committee’s December 2022 meeting.

The recommended medicines include:

• Hemgenix (etranacogene dezaparvovec) as an advanced therapy medicinal product and as the first gene therapy for the treatment of severe and moderately severe Hemophilia B
• Imjudo (tremelimumab) to be used in combination with Imfinzi (durvalumab) for the treatment of adults with hepatocellular carcinoma
• Tremelimumab AstraZeneca (tremelimumab) for the treatment of metastatic non-small lung cancer in combination with Imfinzi and platinum-based chemotherapy
• Pombiliti for the treatment of glycogen storage disease type 2, or Pompe disease
• Dimethyl fumarate Accord (dimethyl fumarate) for the treatment of multiple sclerosis.

With these positive reviews, the CHMP also recommended the refusal of a marketing authorization for Omblastys for the treatment of neuroblastoma, which is a rare type of cancer.

In terms of extensions, the committee recommended Adcirca, Dupixent, Edistride, Enhertu, Fintepla, Forxiga, Hemlibra, Imfinzi (including two new indications), Kerendia, Spikevax and Triumeq.

Source: European Medicines Agency