AstraZeneca/Merck's Selumetinib NDA Gets FDA Priority Status

AstraZeneca plc (NYSE:AZN) and partner Merck (NYSE:MRK) announced that the FDA has accepted the new drug application (NDA) seeking approval of MEK 1/2 inhibitor selumetinib for the treatment of pediatric patients with neurofibromatosis type 1 (NF1) related plexiform neurofibromas (PN), an incurable genetic condition.

With the FDA granting priority review to the NDA, a decision is expected in the second quarter of 2020. The NDA filing was based on positive data from the SPRINT phase II study, testing selumetinib as an oral monotherapy in pediatric patients aged three years or older with inoperable NF1-related PN. Results from the study have shown that selumetinib shrank tumors in children and young adults with NF1 and may improve symptoms such as pain and reduced mobility resulting from tumors, which develop in many people with NF1.

AstraZeneca’s shares have rallied 24.7% this year so far compared with the industry’s growth of 3.8%.

Please note that selumetinib was granted Breakthrough Therapy status and Orphan Drug designation by the FDA in April 2019 and February 2018, respectively, and Orphan designation by the European Medicines Agency (EMA) in August 2018 for the same indication.

AstraZeneca and Merck are jointly developing and commercializing selumetinib globally for multiple cancer types, per a deal signed in July 2017. Meanwhile, under the same deal, the companies also share development and commercialization of successful PARP inhibitor, Lynparza.

In a separate press release, AstraZeneca announced that the European Commission has granted marketing approval to its Qtrilmet modified-release tablets for type II diabetes. Qtrilmet is a combination of AstraZeneca’s other diabetes drugs Farxiga (dapagliflozin) and Onglyza (saxagliptin) plus metformin. It was approved by the FDA with the trade name of Qternmet XR in May.

Zacks Rank and Stocks to Consider

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

Some better-ranked large-cap pharma stocks are GlaxoSmithKline (NYSE:GSK) and Novo Nordisk (NYSE:NVO) , both enjoying a Zacks Rank #2 (Buy).

Glaxo’s earnings estimates have increased 6.2% for 2019 and 2% for 2020 over the past 60 days. The company’s shares have increased 14.8% this year so far.

Shares of Novo Nordisk have risen 25.7% this year so far. Earnings estimates for 2019 and 2020 have risen 0.8% and 1.0%, respectively, over the past 60 days.

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