AstraZeneca PLC on Monday said it won two recommendations for approval in the EU and one priority review in the US.

AstraZeneca’s and Daiichi Sankyo Co Ltd’s breast cancer drug Enhertu won strategic priority review in the US for patients with some forms of breast cancer. ‘Enhertu is a specifically engineered HER2-directed antibody drug conjugate,’ AstraZeneca, a Cambridge-based pharmaceutical company, explained. HER2 stands for human epidermal growth factor receptor 2, a protein that promotes the growth of cancer cells.

Enhertu was approved in the EU last Tuesday.

The priority review in the US comes after Enhertu received breakthrough therapy designation in April in the country, which is granted for drugs that treat serious and life-threatening conditions.

Last Wednesday, Daiichi said it was ordered to pay $41.8 million to biotechnology firm Seagen Inc as a court found Enhertu infringed Seagen’s US patent. Daiichi back then said it will continue to ‘vigorously defend its rights and explore available post-trial motions and remedies’ to contest the judgement and damages awarded to Seagen.

Meanwhile, Astra’s asthma candidate Tezspire received a recommendation for approval in the EU from the Committee for Medicinal Products for Human Use, or CHMP.

People with ‘severe asthma with no phenotype or biomarker limitations’ could receive the drug in the EU if approved.

‘Tezspire consistently and significantly reduced asthma exacerbations across Phase II and III clinical trials, which included a broad population of severe asthma patients irrespective of key biomarkers,’ AstraZeneca explained.

Tezspire was approved in the US for people aged 12 and over in December 2021.

Further, the company’s Ultomiris, a candidate for an autoimmune disease, also received a recommendation for approval in the EU from the CHMP.

People with a form of the autoimmune neuromuscular disease generalised myasthenia gravis could receive treatment with Ultomiris as it ‘showed early effect and demonstrated clinical improvement in activities of daily living,’ Astra said.

About 89,000 people in the EU provably live with the disease, it added. Ultomiris was approved in the US in April and is undergoing regulatory approval in Japan.

AstraZeneca shares were 0.5% higher at 10,818.00 pence each in London on Monday morning.

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