Novartis' (NVS) BLA for Ophthalmology Drug Accepted by FDA

Novartis AG NVS announced that the FDA accepted its Biologics License Application (BLA) for ophthalmology candidate, brolucizumab (RTH258).

Novartis is seeking FDA approval of the candidate for the treatment of wet age-related macular degeneration (AMD), also known as neovascular AMD or nAMD.    

The filing was based on encouraging phase III data from HAWK and HARRIER trials.

We note that Novartis used a priority review voucher to expedite review of brolucizumab in the United States. If approved, the company expects to launch the drug by the end of this year.

Per estimates, approximately 0.5 to 1.75 million people in the United States will be suffering from wet AMD by 2020. The disease is a leading cause of blindness, and hence there is a significant market potential for brolucizumab upon approval.

However, competition is stiff in the wet AMD space from the likes of Regeneron’s REGN Eylea and Roche’s RHHBY Lucentis, among others.

Shares of the company have gained 10.4% in the past six months compared with the industry's 1.5% growth.

Last year was a transformative one for Novartis, as it restructured business to become a core drug-focused company, powered by data and digital technologies. The company acquired AveXis, Inc., a U.S.-based clinical-stage gene-therapy company, in 2018. Novartis also acquired Endocyte to expand expertise in radiopharmaceuticals. We expect more acquisitions in the coming months, as the company looks to further restructure its business.

Approval of new drugs and label expansion of existing drugs bode well for Novartis, as it looks to streamline its business.

In September 2018, the company agreed to sell selected portions of its Sandoz U.S. portfolio, specifically the Sandoz U.S. dermatology business and the U.S. oral solids portfolio. The divestiture is in accordance with Sandoz’s strategy of focusing on complex generics, value-added medicines and biosimilars to achieve sustainable and profitable growth in the United States in the long run. The transaction will be completed this year. Novartis also sold its stake in consumer healthcare joint venture to GlaxoSmithKline GSK for $13 billion.

Zacks Rank

Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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