Applying for PRIME EMA status in the EU

Challenge:

Our client was developing oncolytic viruses for treating a rare form of brain cancer. Its lead product had been successfully evaluated in a Phase I dose-escalation study. Direct injection of the therapeutic into human tumors also led to extensive tumor reduction with no harm to normal brain cells, with extended patient survival appearing to correlate with radiological complete responses. The company wished to obtain PRIME (PRIority MEdicines) approval for the product in the EU, which would designate it a Priority Medicine.

Solution:

Alacrita successfully supported the client application for PRIME status in the EU with the following tasks:

• Preparation of Letter of Intent, draft questions and company positions;
• Preparation of briefing book (Indication, CMC, Non-clinical and clinical background), bibliography and references;
• Submission of the draft package and letter of intent to the EMA;
• Preparation & Attendance at the pre-submission meeting;
• Preparation of meeting minutes and follow-up activities for the final package.

Alacrita's Regulatory Affairs Expertise

Our regulatory affairs consultants can help you devise effective regulatory strategies to place you on the best path torward regulatory approval, helping you avoid regulatory delays and overcome critical regulatory hurdles. We also provide hands-on support, including assistance with regulatory applications and eCTD publishing.