AstraZeneca (LON: AZN) has received two separate European regulatory recommendations in one morning, covering two unrelated treatments from different parts of the business. The European Medicines Agency’s Committee for Medicinal Products for Human Use, known as the CHMP, issued a positive opinion for Enhertu as an adjuvant treatment, given after surgery, for adults with resected HER2-positive breast cancer who still had residual disease following pre-surgery taxane-based chemotherapy and HER2-targeted therapy.
The recommendation rests on the DESTINY-Breast05 Phase III trial, which enrolled 1,635 patients and found Enhertu cut the risk of invasive disease recurrence or death by 53% compared with trastuzumab emtansine, the current standard adjuvant treatment. At three years, 92.4% of patients on Enhertu were alive and free of invasive disease, against 83.7% on the older drug. Susan Galbraith, AstraZeneca’s executive vice president of oncology haematology research and development, said the result could change how the disease is treated after surgery.
“This positive CHMP opinion marks a significant step towards bringing Enhertu into early-stage HER2-positive breast cancer in the EU. Enhertu cut the risk of disease recurrence by more than half compared to adjuvant standard of care for patients with residual disease, and if approved could redefine post-surgery care in the EU, keeping patients disease-free for longer and increasing the potential for cure.” – Susan Galbraith, AstraZeneca
On the same morning, Alexion, AstraZeneca’s rare disease unit, secured its own CHMP recommendation for Klygefa, an antibody-based drug that blocks a protein called C5, for adults with generalised myasthenia gravis whose disease is driven by antibodies against the acetylcholine receptor.
The PREVAIL Phase III trial, covering 260 patients, showed the once-weekly, self-injected drug improved a standard symptom score, the MG-ADL scale, significantly more than placebo by week 26, an effect first seen within a week. Marc Dunoyer, Alexion’s chief executive, called it a step towards convenient symptom control for a disease that affects an estimated 82,500 people across the five largest European markets.
Both are CHMP recommendations rather than final approvals. The European Commission, which has the legal power to grant EU-wide marketing authorisation, typically issues its decision around 67 days after a positive opinion, so neither drug is yet approved in the EU for these uses.
AstraZeneca shares were trading around 12,442p in pre-market dealing today, down about 0.46% from Friday’s close of 12,500p, within a 12-month range of roughly 9,650p to 15,540p.
Enhertu is already approved in the US for this adjuvant use, and Klygefa is already approved in Japan for certain myasthenia gravis patients, so, if the European Commission follows the CHMP’s recommendation as expected, today’s news would extend existing franchises into the EU market rather than validate an entirely new drug.