Soliris, a Treatment for aHUS, Is Now Available in China
Chinese authorities also approve the drug's use for myasthenia gravis in adults
Soliris (eculizumab), an approved treatment for atypical hemolytic uremic syndrome (aHUS), is now available to patients in China, AstraZeneca announced.
“This milestone reflects our ambition to bring transformative, rare disease medicines to the significant number of patients and families living with rare diseases in China who currently have limited treatment options or no available treatment at all,” Leon Wang, executive vice president, international and China president of AstraZeneca, said in a press release.
Soliris was developed by Alexion Pharmaceuticals, which was acquired by AstraZeneca last year.
“Expanding access to our medicines is possible because of the combined strength of Alexion’s rare disease expertise and AstraZeneca’s vast global footprint, and we look forward to continue bringing our therapies to people living with rare diseases around the world in the future,” said Marc Dunoyer, CEO of Alexion.
In aHUS, a part of the immune system called the complement cascade is overactive, leading to inflammation and clotting in small blood vessels that give rise to disease symptoms. Soliris is designed to block the activation of the complement cascade by binding to a protein called C5. It is administered via infusion into the bloodstream every week for five weeks, then every other week thereafter.
Clinical trials of Soliris showed that it reduces inflammation and blood clotting and helps to improve kidney function in people with aHUS. The medication has been approved to treat aHUS in the U.S. and the EU since 2011.
In China, Soliris has been approved to treat aHUS and paroxysmal nocturnal hemoglobinuria (PNH), another disease characterized by complement overactivation that causes blood cell damage. Chinese authorities have also recently approved a supplementary application authorizing Soliris to be used for the treatment of adults with refractory generalized myasthenia gravis, a complement-driven autoimmune disease characterized by muscle weakness.
The National Medicine Products Administration of China (NMPA) has also given AstraZeneca permission to start clinical trials testing other experimental therapies for other conditions like lupus nephritis, a severe form of lupus characterized by kidney damage.
“These milestones represent significant progress against our commitment to expand access to our rare disease medicines globally, including the introduction of innovative rare disease therapies in China,” Dunoyer said.
“We look forward to advancing our commitment in China and aim to bring additional, innovative therapies to even more rare disease patients across the country,” Wang said.
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