European Commission

The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Type II variation application to the European Medicines Agency (EMA) seeking approval of Carvykti (ciltacabtagene autoleucel; cilta-cel) for relapsed and lenalidomide-refractory multiple myeloma. The application is supported by data from the Phase III CARTITUDE-4 study, which evaluated the safety profile and efficacy of cilta-cel […]

DDW’s Diana Spencer explores the European Commission’s proposed changes to EU pharmaceutical legislation, the reaction from industry and possible impact on smaller companies. The European Commission (EC) has proposed the largest reform to the EU’s pharmaceutical legislation in over 20 years. The EC says the revisions will make the system more agile, flexible, and adapted to the needs […]

The European Commission (EC) has granted marketing authorisation for Akeega (niraparib and abiraterone acetate [AA]) for adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic). The drug is given in the form of a dual action tablet (DAT), with prednisone or prednisolone, and is approved in patients for whom chemotherapy is […]

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico1. Politico published a summary of the key propositions outlined in the draft2, and DDW’s Multimedia Editor Megan Thomas investigates their intention, and observes how the industry has responded.   Key proposals   Approved […]

The European Commission and the UK Government have reached a political agreement that they hope will address the challenges faced by citizens and businesses in Northern Ireland (NI) following Brexit. The Windsor Framework, which focuses on a variety of issues, including supply of medicines, constitutes a comprehensive set of joint solutions aimed to ensure lasting […]

The European Commission has granted conditional marketing authorisation for CSL’s Hemgenix (etranacogene dezaparvovec), the first one-time gene therapy for severe and moderately severe haemophilia B (congenital Factor IX deficiency) in adults without a history of Factor IX inhibitors.   In an ongoing clinical trial, the drug reduced the rate of annual bleeds with a single infusion […]

UCB’s Fintepla (fenfluramine) oral solution has been approved in the European Union (EU) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS).  It has received authorisation as an add-on therapy to other anti-epileptic medicines for patients two years of age and older.  The approval was based on safety and efficacy data from a global, […]

Pierre Fabre will commercialise and distribute the first approved allogeneic T cell immunotherapy in Europe following the transfer of the European Commission marketing authorisation of Ebvallo (tabelecleucel) from Atara Biotherapeutics.  Ebvallo is the only approved therapy for the treatment of relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD) in the EU.  Pierre […]

Enhertu has been approved in the EU as the first HER2 directed therapy for patients with HER2 low metastatic breast cancer.  The drug is approved as monotherapy for adult patients who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.  Enhertu is a […]

The European Commission has granted orphan designation for Krystal Biotech’s KB407 for the treatment of cystic fibrosis (CF).  KB407 is an investigational, redosable gene therapy designed to correct the underlying cause of cystic fibrosis by delivering two copies of the CFTR gene directly to the airway epithelial cells when delivered via a nebuliser.   By inducing […]