Multiple sclerosis drug from Biogen, AbbVie clears regulatory hurdle in EU
- An injectable drug for multiple sclerosis from Biogen and AbbVie was recommended for approval by the European Medicines Agency last week, potentially adding a new option for treatment of relapsing forms of the immune system disorder. Zinbryta (daclizumab) is a monoclonal antibody that binds to the IL-2 receptor on T-cells, thereby dampening the body's erroneous targeting of the central nervous system.
- Two phase three trials demonstrated Zinbryta reduced annualized relapse rates (ARR) in patients with relapsing MS, as well as decreasing the risk of 24-week confirmed disability progression, compared to Biogen's existing Avonex treatment.
- Zinbryta is also being reviewed by regulatory authorities in the US, Switzerland, Canada ,and Australia. The European Commission usually makes a final decision based on the EMA's recommendation within months.
Biogen's Avonex (interferon beta-1a) was approved by the FDA in 1996 and had the distinction of being the first drug to slow the progression of RMS, in addition to reducing the AAR. Since then, Avonex has held a strong market position despite the entry of newer oral MS drugs, including the company's own Tecfidera (dimehtyl fumarate).
As Avonex starts to lose market share (Q1 2016 sales were down 19% to $564 million), Biogen is looking towards Tecfidera (Q1 sales were up 15% to $946 million) to strengthen the performance of its MS portfolio. With the EMA's recommendation, it may be able to add Zinbryta to its MS arsenal.
Zinbryta combines the efficacy of Avonex---a daily intramuscular injection---with the convenience of a once-monthly, under the skin injection. The two drugs had similar safety profiles.
“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, chief medical officer at Biogen.
The two companies are jointly developing the drug.