資料來源：https://www.nasdaq.com/article/jazz-pharma-completes-nda-filing-for-leukemia-drug-to-fda-cm769615

JAZZ recently announced that it has completed the rolling submission of a new drug application (NDA) to the FDA, seeking approval for its experimental candidate, Vyxeos (cytarabine and daunorubicin liposome injection). The product will be used for the treatment of acute myeloid leukemia (AML).

We note that Vyxeos, which became part of the company's pipeline following the Jul 2016 Celator acquisition, has Fast Track designation in the U.S. The company intends to seek priority review for the candidate as well.

Moreover, Vyxeos enjoys Breakthrough Therapy designation and was even granted Orphan Drug status by the FDA and the European Commission for AML. The company expects to submit a marketing authorization application (MAA) to EMA in the second half of 2017.

Jazz's shares have outperformed the Zacks classified Medical-Drugs Market industry so far this year. Shares of the company gained 31.2% while the industry registered an increase of 2.6%.

Coming back to the latest news, the rolling submission of 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.

AML is a life-threatening blood cancer, which according to estimates by the American Cancer Society, is likely to result in more than 10,000 deaths in the U.S. in 2017. The American Cancer Society estimates that there will be more than 21,000 new cases of AML in the country this year. Hence, the potential market opportunity for the drug is huge in the U.S.

Please note that no new approved therapies demonstrated overall survival benefit in AML in over 20 years in the U.S. No doubt, an approval will be a huge boost for the company as Vyxeos has the potential to generate blockbuster sales in the target markets.