BRIEF—Sobi to request re-examination of emapalumab MAA in Europe

Swedish Orphan Biovitrum, also known as Sobi, said that, following the negative opinion recommending a refusal to its marketing authorization application (MAA) by the European Medicines Agency’s Committee for Medicinal Products for Human use (CHMP) for its emapalumab, the company will apply for a re-examination.

Emapalumab is intended for the treatment of primary hemophagocytic lymphohistiocytosis (HLH) in children under 18 years of age in Europe.

Given the significant unmet medical need that emapalumab addresses in patients with primary HLH with no approved treatments in Europe, Sobi will be requesting a re-examination by the CHMP with an expected opinion by end of year 2020.

“Emapalumab has demonstrated a positive benefit/risk profile in primary HLH in a post-approval real life setting in the US since the FDA approval in 2018. The product has been able to make a substantial difference for a very vulnerable group of patients in the US. We are proud of having made a significant contribution with our product in the primary HLH indication and we are gratified by the recent academic validation of our work via publication in the New England Journal of Medicine. During the last years our team has gained a lot of experience in this rather complex disease area. We will do our utmost to share these insights and address the open questions by CHMP during the re-examination with a view to secure access for primary HLH in children to this treatment in Europe,” says Guido Oelkers, chief executive and president of Sobi.