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
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
