29th Mar 2016 06:09
LONDON (Alliance News) - Blue-chip drug makers AstraZeneca PLC and GlaxoSmithKline PLC both have secured product approvals in Japan, the companies said Monday.
AstraZeneca said it has secured approval for its Tagrisso drug as a treatment for patients with non-small cell lung cancer resistant to EGFR tyrosine kinase inhibitor therapy.
"We continue to move at an unprecedented pace with osimertinib, with the full approval in Japan following closely the recent US and EU approvals. As first-in-class lung cancer treatment directed at the T790M mutation, we are delighted that this targeted medicine is now available to patients in Japan to address the existing unmet medical need," said Sean Bohen, vice-president of global medicines development and chief medical officer at AstraZeneca.
Meanwhile, Glaxo has received marketing approval in Japan for its Nucala drug as a treatment for bronchial asthma in patients with refractory asthma whose symptoms are not adequately controlled using standards asthma treatments.
The approval comes four months after Nucala was approved for treatment in the US.
"Approval of Nucala not only complements our respiratory portfolio but also gives us the opportunity to make a difference to the lives of more patients in Japan. It is our aim to make Nucala available in Japan as soon as possible to support the needs of a significant group of severe asthma patients whose condition is driven by eosinophilic inflammation, which is difficult to control," said Philippe Fauchet, president of Glaxo Japan.
By Sam Unsted; [email protected]; @SamUAtAlliance
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