(Correcting the phase of the OlympiA trial.)
(Alliance News) - AstraZeneca PLC on Thursday shared its latest regulatory successes in a key market, winning approvals for three treatments in Japan.
The Cambridge-based pharmaceutical firm said Japan's Ministry of Health, Labour & Welfare signed off on three medicines for different indications.
Tagrisso, or osimertinib, is now approved for epidermal growth factor-mutated non-small cell lung cancer after surgery. The approval was based on the results from the Adaura phase III trial which showed a statistically significant and clinically meaningful improvement in disease-free survival.
Tagrisso is an epidermal growth factor receptor tyrosine kinase inhibitor.
Ultomiris, or ravulizumab, is now approved for adults with generalised myasthenia gravis - a rare, debilitating, chronic condition that causes muscle weakness. The approval covers patients with gMG who are anti-acetylcholine receptor antibody-positive, and who do not respond well to certain existing treatments.
The approval for humanized monoclonal antibody was based on results from the Champion-MG phase III trial, which showed the drug outperformed placebo in improving patients' abilities to perform daily activities.
Finally, Lynparza, or olaparib, was approved as an adjuvant treatment for BRCA-mutated, HER2-negative early breast cancer, with a high risk of recurrence.
The PARP inhibitor drug was co-developed with Merck & Co, and is approved for various indications across the globe, including the US, EU and Japan.
This most recent approval was based on the results from the OlympiA phase III trial, which showed a statistically significant and clinically meaningful improvement in invasive disease-free survival.
Shares in AZ closed up 1.0% to 11,465.41 pence in London on Thursday.
By Elizabeth Winter; elizabethwinter@alliancenews.com
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