Alexion is currently pursuing a patent for additional indications of Soliris, including for the treatment of anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG).
Myasthenia gravis, or MG, is a chronic neuromuscular disorder. AchR antibodies inhibit acetylcholine, a neurotransmitter that sends messages between nerve cells, leading to loss of muscle function.
Soliris is a first-in-class complement inhibitor that works by blocking the terminal part of what scientists call the complement cascade, a part of the immune system that when activated in an abnormal way can trigger serious and rare disorders. Soliris targets the underlying cause of gMG by preventing the immune system from becoming abnormally activated.
The European Union approved Soliris in August 2017 after the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the approval in July. Soliris was approved as the first and only treatment in the EU for refractory gMG in patients who have AchR antibodies.
The U.S. Food and Drug Administration (FDA) approved Soliris for gMG patients who have AchR antibodies last October.
The Japanese Ministry of Health, Labor and Welfare has accepted for review a new drug application for Soliris for the same gMG population.
“Alexion is pleased that the JPO has granted an additional patent for Soliris, enhancing our global portfolio of intellectual property protection for this novel complement inhibitor,” Ludwig Hantson, chief executive officer of Alexion, said in a press release. “As we continue to serve patients in Japan and invest in additional research and development for Soliris, we look forward to working with other jurisdictions around the world to further strengthen our patent portfolio.”
The Japanese authorities’ decision follows the issuance of three patents in the United States by the U.S. Patent and Trademark Office (USPTO) earlier this year. The three patents are directed to the composition of matter of eculizumab, pharmaceutical formulations of eculizumab, and methods of treating paroxysmal nocturnal hemoglobinuria (PNH) with eculizumab. All three patents will also expire in 2027.