Novartis NVS recently announced that the European Commission (“EC”) has approved a label expansion of its ophthalmology drug Beovu (brolucizumab).

The EC approved Beovu for the treatment of visual impairment due to diabetic macular edema (DME). This the second indication for which the drug has been approved in the European Union.

Beovu was approved for the treatment of wet age-related macular degeneration in 2020.

DME is a common microvascular complication in patients with diabetes that may have a debilitating impact on visual acuity.

The approval was based on year one data from the phase III, randomized, double-masked KESTREL and KITE studies evaluating Beovu 6 mg versus Regeneron’s REGN Eylea (aflibercept) in DME patients. Beovu was non-inferior to Eylea in change in best-corrected visual acuity (BCVA) from baseline and showed potential for fluid resolution in numerically more DME patients.

Per the companies, KESTREL and KITE were the first pivotal trials to assess an anti-VEGF on six-week dosing intervals in the loading phase, suggesting Beovu may offer fewer injections from the start of treatment through year one.

Beovu is also under review for the DME indication in the United States.

Meanwhile, additional studies evaluating the impact of brolucizumab in patients with wet AMD, DME and proliferative diabetic retinopathy (PDR) are ongoing.

Regeneron’s key growth driver, Eylea, continues to generate revenues for the company on consistent label expansions. It is approved for wet AMD, DME and macular edema following retinal vein occlusion, including macular edema following central retinal vein occlusion and macular edema following branch retinal vein occlusion. Regeneron is working on expanding the drug’s label into additional indications, which will further boost sales.

Approval of new drugs and label expansion of existing drugs are likely to boost Novartis’ top line in the days to come.

Shares of Novartis have gained 0.3% so far this year compared with the industry’s growth of 4.1%.

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The FDA recently approved Novartis’ targeted radioligand therapy, Pluvicto, for the treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer.

Novartis has a strong and diverse portfolio. Solid momentum in key brands like psoriasis drug Cosentyx, cardiovascular drug Entresto, gene therapy Zolgensma, the oncology portfolio and the launch of Kesimpta continue to boost performance.

Novartis has streamlined its business significantly and is looking forward to focusing on its core business. NVS is still evaluating whether to retain or sell its generic business and expects to provide an update on the same by the end of this year.