New information regarding Oncopeptides’ appeal of U.S. withdrawal published
Additional information regarding the formal request from the U.S. Food and Drug Administration (FDA) to voluntarily withdraw Pepaxto’s approval in the U.S has been made available in the public docket. You can access the materials through the following link: https://www.regulations.gov/docket/FDA-2023-N-3167
The first documents posted is a response by Oncopeptides to the Center for Drug Evaluation and Research’s (CDER) response document to Oncopeptides appeal, while the second contains information including an agenda for a joint meeting between on the Center for Drug Evaluation and Research’s (CDER’s) and Oncopeptides hosted by Dr. Peter Marks to be held on October 2, 2023.
What does this mean for Oncopeptides?
The documents posted in the public docket contain argumentation from the involved parties as well as procedural information, such as an upcoming meeting on October 2. The foundational fact remains the same: the FDA is looking to withdraw the approval of Pepaxto from the U.S. market, a decision which we have appealed. We look forward to seeing the process through.
Could you estimate the chance of success of this appeal?
We don´t want to speculate on that. While our strong confidence in the product and its ability to help patients suffering from Multiple Myeloma also in the U.S. remains, we need to remember that we currently don´t market Pepaxto in the U.S.
Oncopeptides’ full strategic focus is on the product roll-out in Europe, where we have a marketing authorization and an established marketing company.
I have questions about the contents of the appeal document that you have filed
Reach out to David Augustsson, Director of Corporate Affairs at firstname.lastname@example.org
I have questions about the continued FDA appeal process
At this time we cannot share any more details or information other than what is made public by the FDA through the following links:
We aim to keep the market and other key stakeholders informed as far as possible while still respecting the formal process.