(Alliance News) - AstraZeneca PLC on Wednesday noted that two of its products have made further progress towards regulatory approval in the US and China.
In the US, the Food & Drug Administration has accepted the supplemental biologics license application for Enhertu, and has also granted the medicine priority review for the treatment of patients with HER2-positive gastric or gastroesophageal junction cancer.
Enhertu has been developed jointly by AstraZeneca and Japanese pharmaceutical firm Daiichi Sankyo Co Ltd.
The sBLA was based on results from the Destiny-Gastric01 phase two trial, which demonstrated a statistically significant and a meaningful improvement in the primary endpoint of objective response rate, and overall survival, which was the second endpoint.
The FDA is expected to make their regulatory decision on Enhertu within the first quarter of 2021.
"Once patients with HER2-positive metastatic gastric cancer progress following initial treatment with an anti-HER2 regimen, there are no approved HER2-directed medicines. The prognosis for these patients is poor, as available treatment options offer only limited clinical benefit. This milestone brings us one step closer to delivering a potentially practice-changing medicine to patients with gastric cancer in the US," said Jose Baselga, executive vice president for Oncology.
Also on Wednesday, the FTSE 100 pharmaceutical titan reported that China's National Medical Products Administration has updated the label for Astra's Forxiga to include data from the Declare-TIMI 58 phase three trial.
The trial showed the Forxiga achieved a significant reduction in the composite endpoint of hospitalisation for heart failure or cardiovascular death in patients with type two diabetes and an established cardiovascular disease, compared to placebo.
"Heart failure is one of the first cardiovascular complications for patients with type-2 diabetes. The Declare-TIMI 58 Phase III data show that Forxiga reduces the risk of hospitalisation for heart failure and, with this label update, we look forward to bringing this significant benefit to patients in China," said Ruud Dobber, executive vice president for BioPharmaceuticals.
Shares in AstraZeneca were down 0.6% at 8,012.00 pence on Wednesday morning in London.
By Dayo Laniyan; dayolaniyan@alliancenews.com
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