Novartis Gets Positive CHMP Opinion For Wet AMD Drug Beovu
Zacks Investment Research | Dec 16, 2019 07:37AM ET
Novartis AG (NYSE:NVS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for its wet age-related macular degeneration (AMD) drug, Beovu.
The positive CHMP opinion was based on findings from the phase III, global, head-to-head HAWK and HARRIER clinical trials, wherein Beovu demonstrated non-inferiority to Regeneron (NASDAQ:REGN) and Bayer’s (OTC:BAYRY) market-leading drug, Eylea (aflibercept), in mean change in best-corrected visual acuity from baseline to year one. Results from the trials showed that approximately 30% of patients treated with Beovu gained at least 15 letters at year one.
In a pre-specified secondary endpoint, fewer patients had intra-retinal fluid and/or sub-retinal fluid at week 16 and year one with Beovu. Additionally, more than half (56% in HAWK and 51% in HARRIER) of patients treated with Beovu 6mg maintained a three-month dosing interval immediately after the loading phase through year one.
A decision from the European Commission is expected in the next three months. The commission takes into account the CHMP’s opinion but is not bound by it.
We remind investors that Beovu was approved by the FDA in October. Per the company, the drug is the first FDA approved anti-VEGF to offer greater fluid resolution as compared to Eylea as well as the ability to maintain eligible wet AMD patients on a three-month dosing interval immediately after a three-month loading phase with uncompromised efficacy.
Novartis’ shares have gained 8.4% in the year so far compared with the Zacks Investment Research
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