Novartis Receives EC Approval for Beovu to Treat Wet AMD

Novartis Receives EC Approval for Beovu to Treat Wet AMD
February 19, 2020


Novartis AG (NYSE: NVS) has revealed that the European Commission (EC) has approved its injection, Beovu (brolucizumab), for wet age-related macular degeneration (AMD) therapy, which is the main reason for blindness across the globe. The decision made by the European Commission shall apply to all 27 European Union member states and also the UK, Norway, Iceland, and Liechtenstein. The stock closed at $97.20, down $0.43 or -0.44% from the previous close.

Excessive VEGF (a protein that assists the growth of abnormal blood vessels beneath the macula, the zone in the retina aiding sharp, central vision) causes wet AMD, a chronic, degenerative eye disease. People aged 65 and over experience extreme vision loss and even blindness due to this disease. It is estimated that roughly 1.70 million people are affected by wet AMD in the European Union alone. Those affected by wet AMD will have blurry or wavy vision initially. As the disease advances, central vision is lost, making it difficult for patients to see objects before them.

The EC gave its approval based on conclusions derived from the Phase III HAWK AND HARRIER clinical tests, in which Beovu fulfilled the primary endpoint, illustrating improvements in BCVA (best-corrected visual acuity) that were not worse to aflibercept at the end of 48th week. Vision improvements at the end of the first year were retained in the second year.

In fluid-associated secondary endpoints, Beovu exceeded the performance of aflibercept. Considerably fewer patients had intra-retinal and/or sub-retinal fluid (IRF/SRF), two fluids “which may disrupt the normal retinal structure and cause damage to the macula (31% for brolucizumab 6 mg vs. 45% for aflibercept in HAWK; 26% vs. 44%, respectively, in HARRIER at year one).”

Furthermore, Beovu indicated outstanding deductions in central subfield thickness, another evidence of retinal fluid, at week 16 and at the end of first year. In both clinical trials, 30% fewer patients had indications of disease activity (Beovu versus aflibercept) at the end of week 16.

More than 50% of patients were kept on a three month dosing interval (51% in HARRIER and 56% in HAWK) during the first year. The rest of the patients in the clinical trial went through a two-month dosing interval.

Christina Fasser, President of Retina International, explained the importance of the approval by the EC. “Today’s 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. This can really help to alleviate a burden, not only on the patient themselves, but also on those who care for them.”

Last October, Novartis was endorsed by the US Food and Drug Administration for Beovu for the medication of wet AMD12. Furthermore, in January 2020, Beovu was approved in Switzerland by Swissmedic and TGA in Australia for wet AMD treatment. Novartis is devoted to bringing Beovu to patients across the globe, and further regulatory filings are being carried out in Japan, Canada, and Brazil.

Marie-France Tschudin, President Novartis Pharmaceuticals, explained how Beovu can serve an AMD patient in a better manner. “Currently, wet AMD patients, who are often older, can face significant challenges in managing their disease. We believe that Beovu, and its ability to resolve fluid, brings great therapeutic value that will help physicians optimize treatments for patients based on disease activity. With the approval of this innovative biologic, Novartis is continuing to reimagine medicine for people living with wet AMD.”

Frank Holz, Professor and Chairman, Department of Ophthalmology, University of Bonn, Germany, opined that Beovu offers an alternative to physicians treating wet AMD. Holz said, “Drying the retina is one of the main goals in the treatment of wet AMD with anti-VEGF therapy. Beovu, with its superior fluid resolution as demonstrated in the HAWK and HARRIER trials, will provide physicians with a new option to treat wet AMD.”

The EC approval for Beovu is expected to turn the stock bullish in the days ahead.

The historical price chart indicates that the stock is trading above its 50-day moving average. The stochastic oscillator is in the bullish region. Therefore, we are anticipating the stock to move up in the days ahead.

nvs - technical analysis - 19th Feb 2020

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