Biogen and AbbVie receive Positive Opinion from the CHMP on Zinbryta for treatment of MS

Positive benefit-risk profile of Zinbryta supported by large head-to-head Phase III DECIDE study.

“For people with relapsing forms of MS (RMS) and active disease, Zinbryta has the potential to offer robust efficacy, a manageable safety profile through patient monitoring, and once-monthly subcutaneous dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen. “Zinbryta may offer another option for people with multiple sclerosis (MS) with its targeted mechanism of action (MOA) which did not cause broad and prolonged immune cell depletion.”

The CHMP positive opinion is now referred to the European Commission (EC), which grants marketing authorizations for centrally authorized medicines in the European Union. A decision from the EC is expected within the coming months.

“Together with Biogen, AbbVie is committed to meeting the needs of patients with MS, and the positive opinion issued by the CHMP is a critical step that moves us closer to bringing Zinbryta to patients in Europe,” said Michael Severino, executive vice president, research and development and chief scientific officer, AbbVie.

According to the CHMP opinion, the benefits of Zinbryta are its ability to reduce the annualized relapse rate (ARR), as well as the risk of 24-week confirmed disability progression. The opinion is based on results from two clinical trials, DECIDE and SELECT, in which Zinbryta 150 mg, administered subcutaneously every 4 weeks improved results on key measures of MS disease activity in patients with RMS compared to AVONEX 30 mcg intramuscular injection administered weekly and placebo, respectively.

In the DECIDE study, the overall incidence of adverse events was similar in the Zinbryta and Avonex groups. In patients treated with Zinbryta compared to Avonex, there was an increased incidence of serious infections (4% versus 2%), serious cutaneous reactions (2% versus <1%), elevations of liver transaminases greater than five times the upper limit of normal (6% versus 3%), gastrointestinal disorders (31% versus 24%), and depression (8% versus 6%).