Biogen and AbbVie receive EU approval for ZinbrytaPharmaceutical Company Product News
Biogen and AbbVie have received European regulatory approval for Zinbryta, their new therapy for relapsing forms of multiple sclerosis (MS).
The once-monthly, self-administered, subcutaneous injection therapy has been granted marketing authorisation by the European Commission for the treatment of adult patients, based on its positive performance in clinical trials.
“Biogen and AbbVie's once-monthly multiple sclerosis therapy Zinbryta has been approved in Europe.“
It was shown to significantly reduce multiple measures of disease activity in patients with relapsing forms of MS without causing any broad prolonged depletion of studied immune cell types.
The phase IIb SELECT and phase III DECIDE studies were used to support the European Commission approval. These involved around 2,400 patients, with DECIDE representing the largest and longest head-to-head phase III study ever conducted in MS.
Dr Alfred Sandrock, executive vice-president and chief medical officer at Biogen, said: "MS manifests differently in each person, with varied symptoms and progressions; therefore, it is important that people living with the disease have treatment choices to address their diverse and evolving needs."
This comes after Biogen's biosimilar anti-TNF therapy Flixabi was also approved in Europe last month.See all the latest jobs in Pharmaceutical