Alexion Pharmaceuticals on Thursday said the FDA has approved Soliris (eculizumab) for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD) who are positive for anti-aquaporin-4 (AQP4) antibodies. John Orloff, head of R&D at Alexion, stated that "today, for the first time, adults living with anti-AQP4 antibody-positive NMOSD have an approved treatment to reduce the risk of an unpredictable relapse, or attack."
Approval of Soliris for this indication was supported by data from the late-stage PREVENT trial, which demonstrated that the drug significantly cut the risk of NMOSD relapse by 94.2% versus placebo.
The FDA assessed Soliris under a priority review for patients with NMOSD and has also granted the therapy orphan drug status, as have regulators in the EU and Japan. The treatment also remains under review for this indication in Europe and in Japan.
Soliris was initially approved by the FDA for the treatment of paroxysmal nocturnal haemoglobinuria in 2007. The indication has since been expanded to include atypical haemolytic uremic syndrome and certain adults with generalised myasthenia gravis.
Sales of Soliris totalled $962 million in the first quarter. In April, Alexion reached a settlement with the US Department of Justice regarding allegations that it used a co-pay assistance foundation to funnel kickbacks in an effort to boost sales of the therapy.
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