AstraZeneca's sNDA for Brilinta Gets FDA's Priority Review
AstraZeneca PLC AZN announced that the FDA has accepted the supplemental New Drug Application (sNDA) for its blood thinner medicine Brilinta (ticagrelor). The company is seeking label expansion of Brilinta for the reduction of subsequent stroke in patients having experienced an acute ischemic stroke or transient ischemic attack (TIA).
With the FDA granting a priority review to the sNDA, its decision is expected in the fourth quarter of 2020.
If approved, Brilinta in combination with aspirin could become the first dual antiplatelet therapy to reduce the rate of stroke in high-risk patients to be approved by the FDA.
The sNDA was based on data from the phase III THALES study, which evaluated the combo of Brilinta (90 mg) plus aspirin in the given patient population. Results showed that treatment with twice daily Brilinta combo led to a statistically significant and clinically meaningful reduction in the risk of the primary composite endpoint of stroke and death versus aspirin alone. The study outcomes were in line with the known safety profile of Brilinta.
The company plans to present data from the THALES study at an upcoming medical conference.
Shares of AstraZeneca have rallied 8.7% so far this year against the industry’s decrease of 1.2%.
In June 2020, the FDA approved Brilinta for reducing the risk of a first heart attack or stroke in high-risk patients with coronary artery disease, which is the most common type of heart disease. The approval was based on findings from the phase III THEMIS study.
We note that Brilinta is one of the key products in the AstraZeneca’s portfolio and is also identified as one of its major growth platforms.
Notably, Brilinta recorded sales worth $408 million in the first quarter of 2020, up 19% year over year driven by continued patient uptake in acute coronary syndrome and high-risk post-myocardial infarction indications. Sales also benefited from short-term inventory increases due to COVID-19. Further label of expansion of the drug will boost sales in future quarters.
Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the large-cap pharma sector include AbbVie Inc. ABBV, H Lundbeck AS HLUYY and Bayer Aktiengesellschaft BAYRY. While AbbVie sports a Zacks Rank #1 (Strong Buy), Bayer and H Lundbeck hold a Zacks Rank #2 (Buy), presently. You can see the complete list of today’s Zacks #1 Rank stocks here.
AbbVie’s earnings estimates have moved 4.9% and 5.4% north for 2020 and 2021, respectively, over the past 60 days. The stock has gained 12.1% year to date.
H Lundbeck’s earnings estimates have been revised 1.8% and 0.5% upward for 2020 and 2021 each over the past 60 days. The stock has inched up 1.6% year to date.
Bayer’s earnings estimates have been revised 4.3% and 4.2% upward for 2020 and 2021, respectively, over the past 60 days.
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AstraZeneca PLC (AZN) : Free Stock Analysis Report
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