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Alexion's Soliris gets EU nod as 1st drug for rare nervous system disorder

Alexion Pharmaceuticals Inc.'s Soliris became the first medicine to be approved in Europe to treat a rare central nervous system disease that usually affects young women.

The European Commission expanded the use of the drug, which is already approved to treat certain rare blood disorders, to include the treatment of the neuromyelitis optica spectrum disorder, or NMOSD, following a recommendation from the European Medicines Agency. Soliris also won U.S. approval for treating NMOSD in June.

The disorder causes the body's immune system to mistakenly attack healthy cells and proteins, primarily in the optic nerves and spinal cord, resulting in blindness and paralysis. Patients experience repeated attacks separated by periods of remission, and the condition disproportionately strikes young women, with the average age of onset at 39 years, Alexion said in an Aug. 27 press release.

Alexion said the approval was backed by data from a phase 3 trial, dubbed Prevent, which showed that the disease did not recur in nearly 98% of the patients who received Soliris.

The drug is approved in the U.S., EU and Japan, among other countries, for treating paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome — both rare blood disorders. The therapy is also approved in the U.S., EU and Japan for certain types of myasthenia gravis, a chronic autoimmune neuromuscular disease.

Soliris generated sales of $981 million during the second quarter of the year, and its patents are up for review by the European Patent Office, with a decision expected in September. If Soliris loses its patents, biosimilar versions of the medicine could enter the market, eating into Alexion's revenues. However, Alexion is looking at new drug Ultomiris, which has been touted as an improved version of Soliris, to mitigate impacts to its revenue.