Roche wins European approval for subcutaneous NMOSD drug

The Roche Tower
The Roche Tower in Switzerland (By Taxiarchos228 (Own work) [FAL], via Wikimedia Commons)

The European Commission has approved Roche’s Enspryng in neuromyelitis optica spectrum disorder (NMOSD). Roche is looking to subcutaneous administration, which could support dosing at home, to differentiate Enspryng from Alexion’s Soliris in the EU.

Soliris is delivered via infusion. Horizon Therapeutics’s Uplizna, which Viela Bio took to FDA approval last year, is also infused. The delivery routes leave a potential opportunity for an alternative that is faster and more convenient to administer. Roche is trying to position anti-IL-6 antibody Enspryng as that alternative.

“An NMOSD relapse can be devastating, causing permanent neurological damage and disability that accumulates with subsequent relapses, which is why our goal is to prevent them. People with NMOSD now have the flexibility to administer treatment at home, which may alleviate the need to travel for hospital appointments,” Friedemann Paul, professor of clinical neuroimmunology, Charité Universitätsmedizin Berlin, said in a statement released by Roche.

Enspryng is given every four weeks. The dosing schedule is made possible by the use of a recycling antibody technology that enables the drug to stay in the bloodstream for longer and dissociate and rebind to IL-6. Enspryng is recycled back into circulation via the neonatal Fc receptor. Chugai, a member of the Roche Group, developed the molecule using its antibody engineering technologies. 

The authorization comes 10 months after Roche won FDA approval for the drug. Enspryng generated sales of CHF 18 million ($20 million) last year and reeled in a further CHF 14 million in the first quarter of 2021. Roche said it has seen “good uptake” of the medicine “despite COVID-19 restrictions having some impact on potential new patients.” Approval in Europe opens another front in Roche’s attempt to establish Enspryng as a significant commercial product.