Oncopeptides AB, a biotech company focused on R&D of development of therapies to treat haematological diseases, announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for Pepaxti in combination with dexamethasone in the United Kingdom.
The approval of Pepaxti in the United Kingdom is an important milestone for the company that further validates their science and data, Jakob Lindberg, CEO of Oncopeptides AB, said. Jakob Linderg added that Pepaxti provides clinical benefit to the patients with triple class refractory disease, and this is a good news for the patients with multiple myeloma, that has very few treatment options.
The marketing authorization in the UK is based on data collected from the phase 2 HORIZON study, and it is supported by data from the randomized controlled phase 3 OCEAN study. The benefit of the therapy in patients with multiple myeloma having treatment history with no stem-cell transplant has gained additional support with the data from the phase 3 LIGHTHOUSE study.
Pepaxti, in combination with dexamethasone, is indicated to treat adult patients with multiple myeloma who have received at least three lines of therapy in the past. For patients with a prior stem cell transplantation, the time to progress should be at least three years from their previous transplantation.
On August 18, 2022, Pepaxti was granted marketing authorization by the European Commission in Europe, and in the EEA-countries, including Lichtenstein, Norway, and Iceland.