Euro CPMP Views Janssen Drug

In October, the European Commission Committee for Proprietary Medicinal Products adopted opinions on 11 concertation procedures, six multi-state procedures and one opinion pursuant to Article 12 of Directive 75/319/EEC, concerning Janssen's Ergamisol (levamisole).

Janssen had sought authorization in May 1990 for adjuvant treatment in combination with fluorouracil in patients with colon carcinoma Dukes' stage C after surgical resection. A CPMP opinion in June 1993 had required it to make a report on the drug after a year, which it did on June 3, 1994. An assessment report was then circulated, and comments received from member states. The new opinion says Ergamisol meets EU marketing authorization requirements provided it is administered only under strict medical supervision, and that its Summary of Product Characteristics and other medical data note that its contribution to the efficacy of this combination therapy for colon cancer Dukes' Stage C is not elucidated. Janssen is to perform clinical trials to demonstrate this contribution and to submit a further update of clinical trials within a year. On present data, the UK and Belgium are not prepared to grant Ergamisol approval.

Also issued was a Coordinated Review of Glaxo's Inhalation Grade HFA-134A (Marketletter October 31). Adopted as final were a Note for Guidance on the Summary of Product Characteristics (Part IB) for benzodiazepines as anxiolytics or hypnotics (III/3653/91 revision 1), and the Notice to Applicants: Format for Part 1A of the application dossier for national and EU applications after January 1, 1995.