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AstraZeneca's Symbicort Granted Pediatric Exclusivity by FDA

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AstraZenecaAZN announced that the FDA has granted six months of pediatric exclusivity to its Symbicort inhalation aerosol. Symbicort is a combination formulation containing budesonide, an inhaled corticosteroid (ICS), and formoterol - a long-acting beta2-agonist bronchodilator (LABA) - in a single inhaler.

Symbicort is currently approved in the U.S. to treat asthma in patients aged 12 years and more,. Also, it got an approval for the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD) in adults. Notably, it is not approved for pediatric use.

AstraZeneca's share price has declined 15.3% in the past one year, compared with the Zacks classified Large Cap Pharmaceuticals industry's loss of 2.7%.

The FDA's decision to grant pediatric exclusivity was based on the studies conducted in children with asthma aged between 6 and 12 years in response to a Written Request. We remind investors that in November 2016, AstraZeneca had announced positive data from pediatric asthma study. The phase III study results showed that the drug improves lung functioning in pediatric asthma patients of the same age group.

Moreover, results from CHASE 3, a phase III study, evaluated Symbicort Inhalation Aerosol 80/4.5 micrograms versus budesonide 80 micrograms, in pediatric patients. The CHASE 3 study was conducted by the company after the FDA asked for an additional data on budesonide and formoterol, particularly regarding the impact of different doses in pediatric asthma patients aged between 6 and 12 years.

Symbicort is also being studied for mild asthma in two phase III studies - SYGMA1 and SYGMA2. The studies are expected to be completed in second half of 2017. Top-line data are also expected in second half of 2017.

Zacks Rank & Key Picks

AstraZeneca currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Enzo Biochem, Inc. ENZ , Sunesis Pharmaceuticals, Inc. SNSS and Anika Therapeutics Inc. ANIK . While Enzo Biochem and Sunesis sport a Zacks Rank #1 (Strong Buy), Anika carries a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 (Strong Buy) Rank stocks here .

Enz Biochem's loss estimates for 2017 narrowed 5.88% over the past 60 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 22.50%. Its share price was up 39.7% in the past one year.

Anika's earnings estimates for 2016 and 2017 were up 3.9% and 0.5%, respectively, over the last 60 days. The company recorded a positive earnings surprise in each of the last four quarters, the average being 33.14%. Its share price was up 37% in the past one year.

Sunesis' loss estimates narrowed 5.06% and 8.80% for 2016 and 2017, respectively, over the past 60 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 0.54%.

Astrazeneca PLC Price

Astrazeneca PLC Price | Astrazeneca PLC Quote

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Astrazeneca PLC (AZN): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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