PARIS (Agefi-Dow Jones)–The pharmaceutical group Sanofi and its Swedish partner Swedish Orphan Biovitrm (Sobi) announced on Wednesday that the Food & Drug Administration (FDA), the American health authority, had granted the designation of “treatment innovation” to efanesoctocog alpha for the treatment of haemophilia A.
“Efanesoctocog alpha is the first factor VIII replacement to be granted ‘breakthrough therapy’ designation by the FDA, Sanofi and Sobi said in a statement.
“The ‘Innovative Therapy’ designation is intended to expedite the development and regulatory review in the United States of drugs intended to treat serious or life-threatening illnesses,” the two companies added.
“This designation is based on data from the Phase III XTEND-1 study which provided clinically meaningful prevention of bleeding and demonstrated superiority of efanesoctocog alpha over prior factor replacement prophylaxis in terms of prevention the risk of bleeding,” they said.
“Efanesoctocog alpha is an investigational new factor VIII replacement designed to achieve virtually normal factor activity for substantially all of the week, with a single weekly prophylactic dose,” Sanofi and Sobi point out.
The FDA had granted orphan drug designation to efanesoctocog alpha in August 2017 and then priority review in February 2021. Orphan drug status was also granted by the European Commission, in June 2019, to efanesoctocog alpha.
“Regulatory submission in the EU will take place when data from the XTEND-Kids study, conducted in children, become available. These are expected in 2023,” added Sanofi and Sobi.
-Alice Doré, Agefi-Dow Jones; +33 (0)1 41 27 47 90; [email protected] ed: VLV
Agefi-Dow Jones The financial newswire
Dow Jones Newswires
June 01, 2022 01:36 ET (05:36 GMT)