Biogen gets EU approval for subcutaneous Tysabri

Biogen biologics plant in Denmark
Work is underway to use the same data to secure approval for the subcutaneous formulation in the U.S. (Biogen)

Biogen has won approval of a subcutaneous formulation of its multiple sclerosis drug Tysabri in the European Union. The approval positions Biogen to push a version of the blockbuster drug that could be more convenient for patients.

European authorities first approved an intravenous formulation of Tysabri in 2006. That form of the drug generated sales of $849 million outside the U.S. last year, on top of $1.1 billion in Biogen’s home market. Sven Meuth, professor of neurology at the University Hospital of Düsseldorf, made the case for using the subcutaneous formulation instead. 

“SC administration offers an opportunity to receive comparable efficacy and safety to the intravenous formulation with reduced administration time which may be meaningful for patients. For physicians, the SC administration offers the ability to prescribe and administer Tysabri in their practice, providing more locations where patients can be treated,” Meuth said in a statement. 

The European Commission approved the subcutaneous formulation on the strength of the DELIVER and REFINE clinical trials, which found its efficacy, pharmacokinetic and pharmacodynamic profiles are comparable to those of the intravenous version. Safety was consistent, too, with the exception of injection site pain in recipients of subcutaneous doses. 

Work is underway to use the same data to secure approval for the subcutaneous formulation in the U.S. The company submitted a supplemental application to the FDA in June 2020, a few months after making the European filing.

Biogen completed the DELIVER and REFINE clinical trials in 2011 and 2014, respectively. European methods of use patents on Tysabri are due to expire in 2023 and 2027, although the former is subject to a legal challenge.