Create Account
Log In
Dark
chart
exchange
Premium
Terminal
Screener
Stocks
Crypto
Forex
Trends
Depth
Close
Check out our Level2View


Sesen Bio Reports Successful Pre-Submission Meeting With European Medicines Agency For Vicineum


Benzinga | Oct 26, 2020 08:10AM EDT

Sesen Bio Reports Successful Pre-Submission Meeting With European Medicines Agency For Vicineum

Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced that it has completed a successful pre-submission meeting with the European Medicines Agency ("EMA") for Vicineum1 for the treatment of BCG-unresponsive non-muscle invasive bladder cancer ("NMIBC") in Europe.

During the meeting, the EMA addressed product-specific, legal, regulatory and scientific topics related to Vicineum. The information and insights gained from the meeting will help to facilitate the validation of the Marketing Authorization Application ("MAA") and support a smooth evaluation. The agency also provided guidance on various administrative topics which helps to clarify the regulatory path forward.

"We are very pleased to be managing the regulatory process with the EMA efficiently and effectively despite the pandemic. We have conducted productive virtual interactions allowing us to stay on track for regulatory filings in Europe," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Europe represents one of the largest regions in terms of unmet need for patients with NMIBC, and we appreciate the agency's guidance and confidence in Sesen Bio to pursue an MAA submission for approval of Vicineum."

This successful pre-submission meeting with the EMA follows the critical milestone of written notice from the EMA that Vicineum has received confirmation of eligibility to file an MAA under the agency's centralized procedure. Confirmation of eligibility was given in response to the submission of a letter of intent, which notified the EMA that Sesen intended to file an MAA.

The success of the pre-submission meeting, in addition to the receipt of centralized procedure eligibility confirmation from the EMA, are significant milestones toward the Company's regulatory path forward in Europe and reaffirms the Company's intent to complete all necessary pre-submission activities with the EMA by the end of 2020.

1The proprietary brand name, Vicineum is a corporate trademark which has been conditionally approved by the FDA. Final approval of the Vicineum brand name is conditional on FDA approval of the Company's product candidate, oportuzumab monatox. Sesen Bio is currently going through the tradename approval process in Europe for oportuzumab monatox.






Share
About
Pricing
Policies
Markets
API
Info
tz UTC-4
Connect with us
ChartExchange Email
ChartExchange on Discord
ChartExchange on X
ChartExchange on Reddit
ChartExchange on GitHub
ChartExchange on YouTube
© 2020 - 2025 ChartExchange LLC