AstraZeneca's Ultomiris, Tagrisso Treatments Approved in Japan
25 August 2022 - 9:02AM
Dow Jones News
By Anthony O. Goriainoff
AstraZeneca PLC said Thursday that Japan has approved its
Ultomiris treatment for adults with generalized myasthenia gravis,
as well as its Tagrisso treatment for early-stage lung cancer after
surgery.
The Anglo-Swedish pharmaceutical company said the approval by
Japan's Health, Labor, and Welfare Ministry came on the back of the
results from separate Phase 3 trials for both treatments.
Ultomiris has been recommended as an add-on to standard therapy
for the treatment of adult patients with generalized myasthenia
gravis who are anti-acetylcholine receptor antibody-positive.
Generalized myasthenia gravis is a debilitating, chronic,
autoimmune neuromuscular disease that leads to a loss of muscle
function and severe weakness.
The company said that in April, Ultomiris was approved in the
U.S. for adults with anti-AChR antibody-positive gMG, and that
regulatory reviews are continuing in additional countries.
Tagrisso has been approved for the treatment of patients with
epidermal growth factor receptor-mutated non-small cell lung cancer
after surgery.
The company said Tagrisso has been approved to treat early-stage
lung cancer in over 85 countries including the U.S., China as well
as the EU, adding that additional global regulatory reviews are
continuing.
Write to Anthony O. Goriainoff at
anthony.orunagoriainoff@dowjones.com
(END) Dow Jones Newswires
August 25, 2022 02:47 ET (06:47 GMT)
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