In a statement Alexion said the FDA has accepted its filing for Soliris (eculizumab), its C5 complement inhibitor, as a treatment for patients with neuromyelitis optica spectrum disorder (NMOSD), who have anti-aquaporin (AQP4) auto antibodies.

The FDA is due to make a decision by June 28, Alexion said.

Alexion said the filing is supported by data from the PREVENT study in patients with anti-AQP4 auto antibody-positive NMOSD.

NMOSD is a rare, devastating, complement-mediated disorder of the central nervous system characterised by relapses.

Each relapse results in stepwise accumulation of disability, including blindness and paralysis, and sometimes premature death.

Patients who have anti-AQP4 auto-antibodies represent approximately three quarters of all patients with NMOSD.

Soliris has been on the market since 2007, and was first approved by the FDA for the complement-related rare disease paroxysmal nocturnal haemoglobinuria (PNH).

Since then it has also been approved in atypical haemolytic uremic syndrome and generalised myasthenia gravis, allowing Alexion to build a billion-dollar franchise around the super-expensive drug.

Alexion’s last set of full year results show the drug generated revenues of more than $3.56 billion, bringing in the lion’s share of total sales, which stood at $4.13 billion for 2018.

Biosimilar competition from the likes of Amgen could become an issue in the coming years as Soliris’ main patent is due to expire in 2021 and 2020 in the US and EU respectively.

But the Connecticut-based pharma has won three new patents on Soliris in the US that are valid until 2027.

It has also produced a longer-acting version, Ultomiris (ravulizumab), which is administered every eight weeks, as opposed to every fortnight with Soliris.

The European Medicines Agency (EMA) is also reviewing a filing for Soliris in NMOSD, and the company is also preparing a filing in Japan due later this quarter.

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