Current regulatory status

The regulatory status provides current information on the Company’s marketing authorizations and regulatory submissions.

Europe

Pepaxti has been granted Marketing Authorization in the European Union, including the EEA-countries Iceland, Lichtenstein and Norway, by the European Commission on August 17, 2022. The product was approved by the Medicines and Healthcare products Regulatory Agency, MHRA, in the UK on November 11, 2022.

Pepaxti is indicated in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.

US

Oncopeptides stopped marketing Pepaxto in the US on October 22, 2021, as per FDA’s request, and the drug is currently not commercially available for patients. On December 7, 2022, the US Food and Drug Administration, FDA, requested Oncopeptides to withdraw the US accelerated approval for Pepaxto, however, Oncopeptides has appealed this request and the appeal procedure with FDA is still ongoing.

Pepaxto was granted accelerated approval in the U.S., on February 26, 2021, and is indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

Pepaxto was voluntarily withdrawn from the US market on October 22, 2021. The withdrawal was rescinded on January 13, 2022, based on further review and analyses of the heterogenous Overall Survival data from the OCEAN study and other relevant studies.