EMA Recommends Five Medicines for Approval
In terms of extensions, the committee recommended Adcirca, Dupixent, Edistride, Enhertu, Fintepla, Forxiga, Hemlibra, Imfinzi (including two new indications), Kerendia, Spikevax and Triumeq.
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
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
