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Novartis' Crizanlizumab Gets Breakthrough Therapy Status

Zacks Equity Research

Novartis AG NVS announced that the FDA has granted crizanlizumab (SEG101) Breakthrough Therapy designation for the prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD). 

Shares of Novartis have increased 4% in the past year compared with the industry’s growth of 5.6%.

 

 

We note that the Breakthrough Therapy designation from the FDA is expected to speed up the development and review of drugs intended to treat serious or life-threatening diseases.

Crizanlizumab, a monthly infusion, is a humanized anti-P-selectin monoclonal antibody that reduces VOCs by binding to a molecule called P-selectin on the surface of platelets and endothelium in the blood vessels. It has been shown to inhibit interactions between endothelial cells, platelets, red blood cells, sickled red blood cells and leukocytes, causing a blockade and thereby preventing these cells from being able to bind to P-selectin.

Breakthrough Therapy designation was based on positive results of the phase II SUSTAIN study, which compared crizanlizumab with placebo in patients with SCD. The study showed that crizanlizumab reduced the median annual rate of VOCs, leading to reduction in health care visits by 45.3%, compared with placebo in patients with or without hydroxyurea therapy. The study also found that crizanlizumab significantly increased the percentage of patients who did not experience any VOCs versus placebo during treatment.

The incidence of treatment-emergent adverse events was 86.4% for patients in the crizanlizumab treatment arm compared to 88.7% for patients in the placebo group, and serious adverse events occurred in 25.8% and 27.4% of patients, respectively. Patients receiving crizanlizumab experienced a low 3% incidence of discontinuations due to adverse events.

Novartis expects to file a new drug application (NDA) for crizanlizumab in the first half of 2019.

The approval of new drugs should boost revenues of the company.

Novartis AG Price

Novartis AG Price | Novartis AG Quote

Zacks Rank and Other Stocks to Consider

Novartis currently carries a Zacks Rank #2 (Buy).

Other top-ranked stocks worth considering are AbbVie Inc. ABBV, Eli Lilly and Company LLY and Merck & Co., Inc. MRK. All of them sport a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

AbbVie’s earnings per share estimates have increased from $7.93 to $7.94 for 2018 and from $8.67 to $8.71 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 3.54%.

Lilly’s earnings per share estimates have increased from $5.53 to $5.59 for 2018 and from $5.81 to $5.92 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 10.03%.

Merck’s earnings per share estimates have increased from $4.71 to $4.72 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 3.96%.

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