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AstraZeneca makes regulatory progress with Enhertu and Forxiga

By Josh White

Date: Wednesday 28 Oct 2020

AstraZeneca makes regulatory progress with Enhertu and Forxiga

(Sharecast News) - AstraZeneca, alongside its partner Daiichi Sankyo, said on Wednesday that 'Enhertu', or trastuzumab deruxtecan, has been accepted by the FDA for its supplemental biologics license application (sBLA).
The FTSE 100 firm said it was also granted priority review in the United States, for the treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.

At the same time, it said China's National Medical Products Administration (NMPA) had updated the label for 'Forxiga', or dapagliflozin), to include data from the 'DECLARE-TIMI 58' phase 3 trial.

For Enhertu, AstraZeneca explained that the Food and Drug Administration (FDA) grants priority review to applications for medicines that offer "significant advances" over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.

The Prescription Drug User Fee Act date, which is the FDA action date for their regulatory decision, would be during the first quarter of 2021.

It said there are more than 27,000 new cases of gastric cancer in the US each year, of which about one in five are HER2 positive.

For patients with metastatic gastric cancer who progressed on initial treatment with an anti-HER2 medicine, there were no other approved HER2-directed medicines.

"Once patients with HER2-positive metastatic gastric cancer progress following initial treatment with an anti-HER2 regimen, there are no approved HER2-directed medicines," said executive vice-president of oncology research and development, José Baselga.

"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."

For Forxiga, AstraZeneca said the DECLARE-TIMI 58 trial showed that it achieved a statistically significant reduction in the composite endpoint of hospitalisation for heart failure or cardiovascular death, compared to placebo, in adults with type-2 diabetes and established CV disease or multiple CV risk factors.

The trial confirmed the "well-established" safety profile of Forxiga, it explained.

DECLARE-TIMI 58 was the largest sodium-glucose cotransporter 2 inhibitor cardiovascular outcomes trial conducted to date, with data from the trial were published in the New England Journal of Medicine in January 2019.

There were an estimated 463 million people living with diabetes worldwide, with nearly 120 million in China.

Patients with type-2 diabetes are two to five times more likely to develop chronic heart failure than those without type-2 diabetes.

"Heart failure is one of the first cardiovascular complications for patients with type-2 diabetes," said executive vice-president of the biopharmaceuticals business unit, Ruud Dobber.

"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."

At 0901 GMT, shares in AstraZeneca were down 0.42% at 8,022.51p.

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