Genzyme and Schering AG Germany await comments from the FDA, following which they hope to resume dosing soon in the Phase 2 clinical trial evaluating Campath for the treatment of multiple sclerosis. The companies submitted a risk-management plan to the FDA and the EMEA earlier this month, which was approved by the study's Data Safety Monitoring Board. Results from a pre-planned interim analysis of the Phase 2 trial were highly encouraging, and the companies are working with participating clinical investigators and regulatory authorities to ensure that a comprehensive program is in place to manage patient safety in both the ongoing Phase 2 and planned Phase 3 studies.
Genzyme will request a meeting with the FDA during the first half of this year to review the proposed protocol for the Phase 3 study, which is now expected to begin during the second half of this year. Additional interim data from the Phase 2 study is expected to be available this year.
http://news.moneycentral.msn.com/provid ... ID=5508707
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