Allergan plc AGN announced that the FDA has approved a label expansion of its anti-infective drug, Avycaz (ceftazidime and avibactam) in pediatric patients. The drug is now approved as monotherapy for complicated urinary tract infections (cUTI), and in combination with metronidazole for complicated intra-abdominal infections (cIAI).
This is the first drug to receive approval for pediatric patients with cUTI or cIAI in more than a decade. The label expansion is likely to boost sales of the drug in future quarters.
We remind investors that the company’s supplemental new drug application (sNDA) for Avycaz was accepted by the FDA in November 2018.
The drug is already approved in adult patients with similar indications. In February 2018, the FDA had approved Avycaz for the treatment of patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) due to gram-negative bacteria.
So far this year, Allergan’s shares have outperformed the industry. The stock has rallied 12.8% in the period, it compared with the 11.6% gain for the industry.
The approval of Avycaz in pediatric patient population, three months and older, was based on data from two active control clinical studies, findings from which were similar to the previous determination of safety for Avycaz, pertaining to the cUTI and cIAI indications in adult patients.
Avycaz recorded sales of $94.6 million in 2018, soaring 54.6% year over year.
Significantly, Avycaz is jointly marketed by Allergan and Pfizer PFE. While Allergan has commercialization rights to Avycaz in North America, the rest of the world rights are owned by Pfizer under the brand name, Zavicefta.
Apart from Avycaz, Allergan’s anti-infectives portfolio comprises antibiotics, namely Teflaro and Dalvance.
Zacks Rank & Stocks to Consider
Allergan currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the pharma sector include Celgene Corporation CELG and Mallinckrodt plc MNK, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Celgene’s earnings estimates have been revised 3.8% upward for 2019 over the past 60 days. The stock has rallied 37.3% so far this year.
Mallinckrodt’s earnings estimates have been revised 10.8% upward for 2019 over the past 60 days. The stock has rallied 43.7% so far this year.
Allergan plc Price
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