Information regarding Oncopeptides’ appeal of U.S. withdrawal published
August 25, 2023
On August 25, 2023, more 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 by the FDA.
The public docket contains, among other documents, a detailed appeal document outlining Oncopeptides’ arguments for why Pepaxto should remain on the U.S. market as an important treatment option for multiple myeloma patients in later lines of treatment.
“Our OCEAN study demonstrated clinical benefit for multiple myeloma patients, in particular for non-transplanted elderly patients where the unmet medical need remains very high, and we remain confident that it would provide value for patients all over the world, including the U.S.,” says Sofia Heigis, CEO of Oncopeptides. “We value the opportunity to share our perspective and look forward to a continued dialogue with the FDA.”
Investor Q&A
What does this mean for Oncopeptides?
The FDA has published certain documents regarding the appeal process that Oncopeptides informed the market about on August 10. The information in the documents have been communicated before, and the foundational fact remains the same: the FDA is still looking to withdraw the approval of Pepaxto from the U.S. market, a decision which we have appealed.
Why didn´t you communicate these documents sooner?
We adhere to the appeals process, which is led by the FDA. We aim to keep the market and other key stakeholders informed as far as possible while still respecting the process.
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 david.augustsson@oncopeptides.com
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:
https://www.federalregister.gov/public-inspection/2023-18320/withdrawal-of-approval-of -new-drug-application-pepaxto-equivalent-to-20-milligrams-base-per-vial
https://www.regulations.gov/docket/FDA-2023-N-3167
We aim to keep the market and other key stakeholders informed as far as possible while still respecting the formal process.
