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AstraZeneca's (AZN) Fasenra Gets FDA Nod for Asthma in Kids

AstraZeneca AZN announced that the FDA has approved its marketed asthma drug, Fasenra (benralizumab), for use in children. The regulatory body has now approved Fasenra as an add-on maintenance treatment for severe asthma in patients aged six to 11 years with an eosinophilic phenotype.

Fasenra is already approved as an add-on maintenance treatment for severe eosinophilic asthma (SEA) in patients aged 12 and older.

The latest approval for Fasenra was based on data from the open-label phase III TATE study, as well as other studies in adult and adolescent patient populations.

Data from the TATE study showed that treatment with Fasenra demonstrated pharmacokinetics and pharmacodynamics in children aged six to 11 years old with SEA, thereby meeting the primary endpoints of the study.

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Importantly, the recommended dose for Fasenra is 30 mg for children aged six years and older weighing 35 kg or more. However, for children who weigh less than 35 kg in the same age group, a new 10 mg dose of Fasenra will now be available.

Shares of AstraZeneca have increased 3.1% so far this year compared with the industry’s 10.8% rise.

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Zacks Investment Research


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Fasenra is currently approved in more than 80 countries across the world including the United States, European Union and Japan for SEA. Several label expansion studies are going on for Fasenra for eosinophil-driven diseases beyond severe asthma like chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome.

Fasenra generated sales worth $1.6 billion in 2023, reflecting an increase of 12% year over year at a constant exchange rate.

Successful label expansion for Fasenra into additional indications and patient populations should boost drug sales in the days ahead.

In a separate press release, AstraZeneca announced a 7% or a 20 cents hike in its annualized dividend taking it to $3.10 per share from $2.90 for 2024. The company has been regularly paying half-yearly interim dividends.

Zacks Rank & Stocks to Consider

AstraZeneca currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the healthcare sector are ADMA Biologics, Inc. ADMA, Ligand Pharmaceuticals Incorporated LGND and ANI Pharmaceuticals, Inc. ANIP, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. Year to date, shares of ADMA have rallied 37.6%.

ADMA’s earnings beat estimates in three of the trailing four quarters and met the same once, the average surprise being 85.00%.

In the past 60 days, estimates for Ligand’s 2024 earnings per share have improved from $4.42 to $4.56. Year to date, shares of LGND have gained 14%.

Earnings of LGND beat estimates in each of the trailing four quarters, the average surprise being 84.81%.

In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.43. Year to date, shares of ANIP have jumped 23.5%.

Earnings of ANIP beat estimates in each of the trailing four quarters, the average surprise being 109.06%.

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AstraZeneca PLC (AZN) : Free Stock Analysis Report

Ligand Pharmaceuticals Incorporated (LGND) : Free Stock Analysis Report

ANI Pharmaceuticals, Inc. (ANIP) : Free Stock Analysis Report

ADMA Biologics Inc (ADMA) : Free Stock Analysis Report

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