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FDA Accepts Allergan's (AGN) sNDA for Anti-Infective Avycaz
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Allergan announced that the FDA has accepted its supplemental new drug application (sNDA) for approval of its antibacterial medicine, Avycaz for the pediatric patient population.
The sNDA is seeking an approval for Avycaz for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI - in combination with metronidazole) in pediatric patients, aged three months and above. Avycaz is already approved to treat these infections in adult patients. The medicine is a combination of avibactam and ceftazidime.
So far this year, Allergan’s shares have outperformed the industry. Although the stock has declined 6.2% in the period, the loss is narrower than the 8.6% decrease of the industry.
The sNDA filing 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 February, the FDA approved Avycaz for the treatment of patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) due to gram-negative bacteria. The approval marked the third therapeutic indication for the drug in the United States.
Avycaz recorded sales of $70 million in the first nine months of 2018, soaring 63.9% year over year.
Significantly, Avycaz is jointly marketed by Allergan and Pfizer (PFE - Free Report) . 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.
Some better-ranked pharma stocks are GlaxoSmithKline plc (GSK - Free Report) and Merck (MRK - Free Report) , both carrying a Zacks Rank #2 (Buy).
Merck’s earnings estimates have risen 1.4% for 2018 and 1.3% for 2019 over the past 30 days. The stock has surged 32.9% so far this year.
Glaxo’s earnings estimates have inched up 0.3% for 2018 and were flat for 2019 over the past 30 days. The stock has rallied 14.6% so far this year.
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Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
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FDA Accepts Allergan's (AGN) sNDA for Anti-Infective Avycaz
Allergan announced that the FDA has accepted its supplemental new drug application (sNDA) for approval of its antibacterial medicine, Avycaz for the pediatric patient population.
The sNDA is seeking an approval for Avycaz for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI - in combination with metronidazole) in pediatric patients, aged three months and above. Avycaz is already approved to treat these infections in adult patients. The medicine is a combination of avibactam and ceftazidime.
So far this year, Allergan’s shares have outperformed the industry. Although the stock has declined 6.2% in the period, the loss is narrower than the 8.6% decrease of the industry.
The sNDA filing 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 February, the FDA approved Avycaz for the treatment of patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) due to gram-negative bacteria. The approval marked the third therapeutic indication for the drug in the United States.
Avycaz recorded sales of $70 million in the first nine months of 2018, soaring 63.9% year over year.
Significantly, Avycaz is jointly marketed by Allergan and Pfizer (PFE - Free Report) . 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.
Allergan 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 pharma stocks are GlaxoSmithKline plc (GSK - Free Report) and Merck (MRK - Free Report) , both carrying a Zacks Rank #2 (Buy).
Merck’s earnings estimates have risen 1.4% for 2018 and 1.3% for 2019 over the past 30 days. The stock has surged 32.9% so far this year.
Glaxo’s earnings estimates have inched up 0.3% for 2018 and were flat for 2019 over the past 30 days. The stock has rallied 14.6% so far this year.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
See the pot trades we're targeting>>