The USFDA has requested the completion of a repeat-dose study before considering potential approval, the company announced.
This development has raised eyebrows in the medical community, as ARS Pharma was seeking approval for Neffy as an emergency treatment for allergic reactions, including anaphylaxis, in both adults and children weighing over 30 kg.
The Unexpected USFDA Decision
ARS Pharmaceuticals, a pioneering player in the pharmaceutical industry, expressed their astonishment at the USFDA’s decision.
“We are very surprised by this action and the late requirement at this time to change the repeat-dose study from a post-marketing requirement, which we had previously agreed on with the USFDA, to a pre-approval requirement, particularly given the favorable Advisory Committee vote,” CEO Richard Lowenthal said.
This shift in regulatory demands adds a new layer of complexity to the approval process.
Timeline for Resubmission
Despite this setback, ARS Pharma remains determined to forge ahead. The company anticipates a resubmission in the first half of 2024, with an USFDA action date slated for the second half of the same year.
Additionally, the company has indicated its intent to appeal the issuance of the USFDA’s Complete Response Letter, demonstrating a steadfast commitment to bringing Neffy to market.
Current Dependence on EpiPen and Autoinjectors
In the interim, patients grappling with severe allergic reactions continue to rely on established emergency treatments like EpiPen and other autoinjectors, such as Sanofi Auvi-Q, which contain the life-saving drug epinephrine.
These medical interventions serve as crucial lifelines for individuals at risk of experiencing anaphylaxis, a life-threatening allergic reaction that can manifest within moments of allergen exposure and, if left untreated, can be fatal.
Trials and Ethical Considerations
ARS Pharma’s application for Neffy was built on comprehensive trials involving both healthy subjects and individuals experiencing rhinitis attacks.
Notably, the nasal spray demonstrated a response comparable to injectable products in delivering epinephrine, a pivotal finding in its developmental journey.
However, it’s important to highlight that the studies did not encompass individuals experiencing anaphylaxis, due to ethical concerns.
Rival Petition for Real-World Testing
In a competitive landscape, rival pharmaceutical company Viatris urged the USFDA to mandate ARS to conduct additional trials that closely mirror real-world conditions.
This request underscores a critical concern within the medical community regarding the lack of studies conducted in actual anaphylactic scenarios.
James Tarbox, an esteemed allergist at Texas Tech University Health Sciences Center, emphasized, “The biggest concern with the nasal spray is that it has not been studied in a real-world setting with people who have suffered anaphylaxis due to ethical purposes.”
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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