AstraZeneca's Fasenra Receives FDA Orphan Drug Designation for Eosinophilic Esophagitis (EoE)

Recently, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that global biopharmaceutical company AstraZeneca announced that its innovative drug Fasenna has received orphan drug designation from the FDA for the treatment of eosinophilic esophagitis (EoE).

Eosinophilic Esophagitis (EoE), also known as allergic esophagitis, is a chronic inflammatory condition of the esophagus characterized by eosinophilic infiltration throughout the entire thickness of the esophageal wall. In adults, common clinical manifestations include dysphagia, food impaction, and reflux-like symptoms; some patients may also experience retrosternal pain, acid regurgitation, and heartburn. In children, the primary presentations are typically food refusal and malnutrition.

The diagnosis of EoE is primarily based on its typical clinical manifestations and esophageal pathological findings in patients. The etiology remains unclear, although some studies suggest a certain degree of familial aggregation associated with this disease.

General management of eosinophilic esophagitis (EoE) includes acid suppression, dietary modification, glucocorticoids, and esophageal dilation, with glucocorticoid therapy being the mainstay. Some patients develop complications such as esophageal strictures, which are often refractory to pharmacologic therapy alone, necessitating mechanical dilation. Currently, there are no FDA-approved therapies for EoE.

Fasenra is the first biologic developed by AstraZeneca for respiratory diseases. It was approved by the FDA in November 2017 as an add-on maintenance treatment for patients aged 12 years and older with severe eosinophilic asthma. Over the past two years, the FDA has successively granted Fasenra orphan drug designation for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES).

Fasenra is a monoclonal antibody that directly binds to the IL-5 receptor on eosinophils and promotes rapid eosinophil death via apoptosis induced by natural killer (NK) cells. In addition to EoE, AstraZeneca is also exploring the efficacy of Fasenra in nasal polyposis and chronic obstructive pulmonary disease (COPD).

AstraZeneca, established in 1999 and headquartered in London, United Kingdom, is a global leading biopharmaceutical company formed by the merger of the former Swedish company Astra AB and the former British company Zeneca Group PLC. The company is primarily engaged in the design, research and development, and sales of prescription drugs, while driving advancements in the healthcare sector, with annual R&D investment exceeding $4 billion. AstraZeneca employs more than 60,000 people, operates in over 100 countries worldwide, and maintains production facilities in 17 countries.

As an innovation-driven pharmaceutical company, AstraZeneca is committed to developing innovative medicines to improve patient outcomes. The company has also established a presence in China, with its business focusing on therapeutic areas such as cardiovascular diseases, metabolic disorders, oncology, respiratory conditions, gastrointestinal diseases, and renal diseases. AstraZeneca has invested over $750 million in China, building production bases in Wuxi and Taizhou, Jiangsu Province. In 2018, the company’s sales revenue in China reached $3.795 billion.

Mene Pangalos, Executive Vice President at AstraZeneca, stated: “Eosinophilic esophagitis (EoE), an allergic inflammatory disease, affects a broad population, with patients typically experiencing a range of debilitating symptoms, including severe pain and difficulty swallowing food. Fasenra can induce the depletion of eosinophils in human blood and tissues, and I believe it has the potential to become a novel therapeutic agent for this rare condition.”

(Compiled by Xu Xiaoxue)