Novartis has announced the receipt of a European Commission (EC) approval for Beovu (brolucizumab), its injection for the treatment of wet age-related macular degeneration (AMD).
The company also confirmed that the therapy is the first EC-approved anti-VEGF treatment to demonstrate superior resolution of retinal fluid, which is a key marker of disease activity, compared to Bayer's Eylea (aflibercept) in the trial’s secondary endpoint.
The EC says that the approval was based on findings from the Phase III HAWK and HARRIER clinical trials, in which Beovu met the primary endpoint, demonstrating gains in best corrected visual acuity (BCVA) that were non-inferior to Eylea at year one.
In addition to this, vision gains at year one were maintained at year two.
The decision comes off the back of the European Medicines Agency (EMA)’s human medicines committee (CHMP) recommendation to approve the drug last December.
Wet AMD is a chronic, degenerative eye disease caused by an excess of VEGF, a protein that promotes the growth of abnormal blood vessels underneath the macula, the area of the retina responsible for sharp, central vision. The disease is a leading cause of severe vision loss and blindness in people over age 65, affecting more than 20 million people worldwide.
The approval is a “step forward for patients in Europe who have been looking for a new treatment option which may help them maintain their sight — and their independence — for longer,” said Christina Fasser, president, Retina International. “This can really help to alleviate a burden, not only on the patient themselves, but also on those who care for them.”
The drug is already approved in the US, getting the nod from the US Food and Drug Administration (FDA) back in October 2019.