The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorisation for Zinbryta (daclizumab) intended for the treatment of relapsing forms of multiple sclerosis (RMS), Biogen and AbbVie announced.
Zinbryta is a once-monthly, self-administered, subcutaneous investigational treatment for RMS. Zinbryta is also currently under regulatory review in the United States, Switzerland, Canada and Australia.
“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 authorisations for centrally authorised 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, M.D., 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 annualised 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 four 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 per cent versus 2 per cent), serious cutaneous reactions (2 per cent versus <1 per cent), elevations of liver transaminases greater than five times the upper limit of normal (6 per cent versus 3 per cent), gastrointestinal disorders (31 per cent versus 24 per cent), and depression (8 per cent versus 6 per cent).
Zinbryta (daclizumab) is an investigational compound being developed for the treatment of relapsing forms of MS. Zinbryta is a new form of a humanized monoclonal antibody that selectively binds to the high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is expressed at high levels on T-cells that become activated in people with MS. Zinbryta modulates IL-2 signaling without general immune cell depletion.
Biogen and AbbVie are jointly developing Zinbryta.