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AZN Gets FDA Nod for Fasenra Label Expansion in Rare Disease
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AstraZeneca (AZN - Free Report) announced that the FDA has approved its marketed asthma drug, Fasenra (benralizumab) for a new indication. The regulatory body has now approved Fasenra for treating adult patients with eosinophilic granulomatosis with polyangiitis (“EGPA”).
EGPA is a rare autoimmune disease that can cause damage to multiple organs and tissues and is the second approved indication for Fasenra.
Fasenra is already approved as an add-on maintenance treatment for severe eosinophilic asthma (SEA).
Shares of AstraZeneca have increased 16.6% so far this year compared with the industry’s rise of 25.9%.
Image Source: Zacks Investment Research
Latest Approval for AZN’s Fasenra Based on MANDARA Study
The FDA nod for Fasenra in EGPA was based on data from the phase III MANDARA study.
The MANDARA head-to-head study compared a single monthly injection of Fasenra to three injections per month of GSK’s (GSK - Free Report) blockbuster drug, Nucala (mepolizumab), which until now was the only approved drug for EGPA.
Data from the study showed that nearly 60% of patients who were treated with Fasenra achieved remission, which was comparable to GSK’s Nucala-treated patients.
Also, 41% of patients who were treated with Fasenra fully stopped taking oral corticosteroids compared to 26% of patients in the Nucala arm.
The latest approval of Fasenra is likely to offer a convenient single monthly subcutaneous injection to patients living with EGPA.
AZN’s Fasenra a Key Revenue Driver
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 $781 million in the first half of 2024, reflecting an increase of 6% year over year at a constant exchange rate. Sales of the drug have been rising, driven by strong demand growth and market share.
Continued label expansion for Fasenra into additional indications and patient populations should boost drug sales in the days ahead.
Other Players in the Respiratory Diseases Market
Apart from GSK’s Nucala, Sanofi (SNY - Free Report) and Regeneron’s (REGN - Free Report) Dupixent (dupilumab), an IL-4 and IL-13 inhibitor, is also approved in several countries, including the United States and EU, for five type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
REGN and SNY are jointly marketing Dupixent under a global collaboration agreement. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the drug’s global sales. The companies are also studying the drug in late-stage studies in a broad range of diseases driven by type II inflammation, like bullous pemphigoid and chronic pruritus of unknown origin.
Image: Bigstock
AZN Gets FDA Nod for Fasenra Label Expansion in Rare Disease
AstraZeneca (AZN - Free Report) announced that the FDA has approved its marketed asthma drug, Fasenra (benralizumab) for a new indication. The regulatory body has now approved Fasenra for treating adult patients with eosinophilic granulomatosis with polyangiitis (“EGPA”).
EGPA is a rare autoimmune disease that can cause damage to multiple organs and tissues and is the second approved indication for Fasenra.
Fasenra is already approved as an add-on maintenance treatment for severe eosinophilic asthma (SEA).
Shares of AstraZeneca have increased 16.6% so far this year compared with the industry’s rise of 25.9%.
Image Source: Zacks Investment Research
Latest Approval for AZN’s Fasenra Based on MANDARA Study
The FDA nod for Fasenra in EGPA was based on data from the phase III MANDARA study.
The MANDARA head-to-head study compared a single monthly injection of Fasenra to three injections per month of GSK’s (GSK - Free Report) blockbuster drug, Nucala (mepolizumab), which until now was the only approved drug for EGPA.
Data from the study showed that nearly 60% of patients who were treated with Fasenra achieved remission, which was comparable to GSK’s Nucala-treated patients.
Also, 41% of patients who were treated with Fasenra fully stopped taking oral corticosteroids compared to 26% of patients in the Nucala arm.
The latest approval of Fasenra is likely to offer a convenient single monthly subcutaneous injection to patients living with EGPA.
AZN’s Fasenra a Key Revenue Driver
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 $781 million in the first half of 2024, reflecting an increase of 6% year over year at a constant exchange rate. Sales of the drug have been rising, driven by strong demand growth and market share.
Continued label expansion for Fasenra into additional indications and patient populations should boost drug sales in the days ahead.
Other Players in the Respiratory Diseases Market
Apart from GSK’s Nucala, Sanofi (SNY - Free Report) and Regeneron’s (REGN - Free Report) Dupixent (dupilumab), an IL-4 and IL-13 inhibitor, is also approved in several countries, including the United States and EU, for five type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
REGN and SNY are jointly marketing Dupixent under a global collaboration agreement. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the drug’s global sales. The companies are also studying the drug in late-stage studies in a broad range of diseases driven by type II inflammation, like bullous pemphigoid and chronic pruritus of unknown origin.
Zacks Rank
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.