Astrazeneca secures two positive regulatory opinions in Europe

(Sharecast News) - Drugmaker Astrazeneca received a double boost on Monday as European regulators issued positive opinions for two of its medicines - Klygefa for generalised myasthenia gravis and Enhertu for early‑stage HER2‑positive breast cancer. Astrazeneca said the EU's Committee for Medicinal Products for Human Use had backed Klygefa (gefurulimab) for adults with AChR‑positive gMG as an add‑on treatment and highlighted that, if approved, it would be the first dual‑binding nanobody C5 inhibitor available in Europe.

The recommendation follows its Phase III PREVAIL study, which showed clear improvements in patients' day‑to‑day symptoms compared with placebo, with benefits appearing within the first week and continuing through the 26‑week trial. Klygefa has already revceived approval in Japan, with applications under review in the US, China and other markets.

AstraZeneca and Daiichi Sankyo also secured a CHMP recommendation for Enhertu (trastuzumab deruxtecan) as an adjuvant option for adults with HER2‑positive breast cancer who still have invasive disease after neoadjuvant therapy.

The opinion was based on the DESTINY‑Breast05 trial, which showed Enhertu cut the risk of the cancer returning or patients dying by 53% compared with T‑DM1. After three years, more than 92% of patients on Enhertu remained free of invasive disease, versus 84% in the comparator group. Enhertu was already approved in the US and other countries for this use.

As of 0915 BST, Astrazeneca shares were down 0.40% at 12,450p.





Reporting by Iain Gilbert at Sharecast.com

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