WILMINGTON, Del. - The US Food and Drug Administration (FDA) has expanded the approval for AstraZeneca (NASDAQ:AZN)'s FASENRA (benralizumab) to include use as an add-on maintenance treatment for children aged 6 to 11 with severe eosinophilic asthma (SEA). Previously approved in 2017 for patients aged 12 and older, this new indication provides a younger pediatric population access to the medication.
FASENRA's extended indication was supported by the TATE Phase III trial, which demonstrated consistent pharmacokinetics (PK) and pharmacodynamics (PD) in the 6 to 11 age group compared to previous trials. The trial also confirmed the safety and tolerability profile of FASENRA.
For patients 6 years and older weighing 35 kg or more, the recommended dose is 30 mg, and for those under 35 kg, a 10 mg dose will be available. FASENRA is administered subcutaneously every 4 weeks for the first three doses and then every 8 weeks thereafter.
The approval is a welcome development for children with SEA, a chronic condition that can significantly impact quality of life, including school performance and increased healthcare resource use. The Allergy & Asthma Network's CEO, Lynda Mitchell, MA, CAE (NYSE:CAE), expressed support for the additional treatment option, emphasizing its potential to address unmet needs in this patient group.
FASENRA, a monoclonal antibody, works by binding to the IL-5 receptor alpha on eosinophils, leading to apoptosis and depletion of these immune cells, which are often elevated in SEA. The drug has been prescribed to over 100,000 patients in the US and is approved for self-administration in multiple countries.
AstraZeneca, a global biopharmaceutical company, continues to focus on respiratory care as a key growth driver. With this approval, FASENRA becomes an integral part of their mission to revolutionize asthma care, particularly for pediatric patients.
The FDA's decision to approve the expanded use of FASENRA for younger patients is based on the results of clinical trials and is contingent upon the safety guidelines provided in the prescribing information.
This includes warnings against the use of FASENRA to treat acute asthma symptoms or during acute exacerbations, the gradual reduction of corticosteroid dosage under physician supervision, and the management of potential hypersensitivity reactions.
The information in this article is based on a press release statement from AstraZeneca.
InvestingPro Insights
As AstraZeneca (NASDAQ:AZN) garners FDA approval for an expanded pediatric use of its asthma treatment, FASENRA, the company's financial metrics provide a snapshot of its current market position and future prospects. With a robust market capitalization of $212.62 billion, AstraZeneca stands as a prominent player in the pharmaceuticals industry.
The company's P/E ratio, as of the last twelve months of Q4 2023, is adjusted to 27.47, indicating a potential value opportunity when paired with near-term earnings growth expectations. This aligns with one of the InvestingPro Tips highlighting that AstraZeneca is trading at a low P/E ratio relative to its anticipated earnings growth.
The company's revenue growth also appears stable, with a 7.29% increase in the most recent quarter of Q4 2023. This incremental growth suggests a consistent demand for AstraZeneca's products, which now includes the newly approved pediatric use of FASENRA.
Furthermore, AstraZeneca's commitment to shareholder returns is underscored by its history of dividend payments, having maintained them for 32 consecutive years—a testament to its financial resilience and strategic planning.
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