Jazz Pharmaceuticals' Vyxeos NDA Granted Priority Review
Jazz Pharmaceuticals plc JAZZ announced that the New Drug Application (NDA) for its experimental leukemia candidate Vyxeos has been accepted for priority review by the FDA.
The specialty biopharmaceutical company is looking to get Vyxeos (cytarabine and daunorubicin liposome injection) approved for the treatment of acute myeloid leukemia (AML), a rapidly progressing and life-threatening blood cancer.
With the FDA granting priority review, a decision should be out within the next six months.
Moreover, Vyxeos enjoys Breakthrough Therapy designation and was even granted Orphan Drug status by the FDA and the European Commission for AML.
A look at Jazz Pharma’s share price movement so far this year shows that the stock has outperformed the Zacks classified Medical - Drugs industry. Specifically, Jazz’s stock gained 33.6% during this period, while the industry increased 3.5%.
Coming back to the latest news, the submission of the NDA was supported by clinical data from five studies, including a pivotal phase III study. Data from the phase III study met its primary endpoint and were presented at the American Society of Clinical Oncology Annual Meeting in Jun 2016. Vyxeos has demonstrated statistically significant improvement in overall survival in trials conducted on patients with high-risk (secondary) AML.
We note that Vyxeos became part of the company’s pipeline following the Jul 2016 Celator acquisition.
Acute myeloid leukemia is a life-threatening blood cancer, which according to estimates by the American Cancer Society, will result in 10,590 deaths in the U.S. in 2017. The American Cancer Society estimates there will be 21,380 new cases of AML in the country this year. An approval would be a huge boost for the company as Vyxeos.
With no new approved therapies demonstrating overall survival benefit in AML in over 20 years in the U.S., Vyxeos should address significant unmet need in an orphan disease.
In Mar 2017, the regulatory authority granted priority review status to enasidenib as well for the treatment of AML. The candidate is being developed by Celgene Corporation CELG and Agios Pharmaceuticals AGIO. Moreover, GlycoMimetics Inc.’s GLYC drug candidate, GMI-1271, has been granted Breakthrough Therapy designation to accelerate the development for treating AML recently in May 2017.
Jazz Pharmaceuticals PLC Price
Jazz Pharmaceuticals PLC Price | Jazz Pharmaceuticals PLC Quote
Jazz Pharmaceuticals has 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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