AstraZeneca's Soliris Treatment Approved in China for Adults With gMG
13 Juni 2023 - 8:58AM
Dow Jones News
By Joe Hoppe
AstraZeneca said Tuesday that its Soliris disease treatment has
been approved in China for adults with refractory generalized
myasthenia gravis, known as gMG.
A rare, chronic, autoimmune neuromuscular disease, gMG leads to
a loss of muscle function and severe weakness.
The pharmaceutical major said the drug--also known as
eculizumab--has been approved for adults with gMG that are
anti-acetylcholine receptor antibody-positive, the third approval
in China for the treatment's use for tackling rare diseases.
The National Medical Products Administration's approval was
based on comprehensive Phase 3 trial results. In the trial, Soliris
demonstrated a clinical benefit in adults that had previously
failed immunosuppressive treatment, and continued to suffer from
significant unresolved symptoms.
Improvements shown over the initial six-month trial duration
were also sustained over a treatment period of more than 130 weeks
in a long-term extension trial, the company added.
The treatment's safety and tolerability profile were consistent
throughout both the primary treatment period and the extension.
Write to Joe Hoppe at joseph.hoppe@wsj.com
(END) Dow Jones Newswires
June 13, 2023 02:43 ET (06:43 GMT)
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