The U.S. FDA has extended the date to complete its review of the neffy nasal epinephrine spray until September 2023.
ARS Pharmaceuticals, which applied for approval of the novel spray to treat severe allergic reactions, said the FDA gives September 19 as the new “target action date”.
In May 2023, a 22-member advisory committee of experts recommended to the FDA that it does approve the epinephrine spray. The FDA is now in the process of reviewing the recommendations, company data and other considerations before making its decision.
The advisory committee voted 16 to 6 to recommend approval of the 2-milligram epinephrine spray for allergic adults. It also voted 17 to 5 to recommend it for children over 30 kilograms, who are at risk for anaphylaxis.
ARS Pharma says that in announcing the extension, the FDA has not requested any further clinical data. “FDA is working on labeling and post-marketing commitments as the final steps in the review process,” said ARS president and CEO Richard Lowenthal. Under the Prescription Drug User Fee Act (PDUFA), the FDA must complete a drug review within in a set number of months.
Lowenthal says that following the committee meeting, “there was limited time to address any final questions and complete labeling. While the agency extended the PDUFA timeline, we are hopeful that labeling discussions will be completed as soon as possible,” he said in a news release. If the FDA decision is favorable, neffy would become the first needle-free epinephrine device available in the U.S.
An ARS spokesperson explained that “post-marketing commitments” refer to “activities after FDA approval of a product to generate additional data about a product’s safety, efficacy or optimal use.” For example, the spokesperson noted that, when first approved, the FDA required EpiPen to maintain a registry to track patient outcomes.
EpiPen Petitions FDA on Neffy
In related news, Viatris Inc. (formerly Mylan), which markets the EpiPen and generic equivalent epinephrine auto-injectors, has filed a “Citizen Petition” with the FDA about neffy (or ARS-1).
Viatris’s head of regulatory affairs writes that “having carefully reviewed the Advisory Committee Meeting materials and other publicly available data on ARS-1, Viatris believes the totality of currently available evidence does not yet answer several critical questions regarding how ARS-1 will perform in a real-world anaphylaxis event.”
The company calls for further study, especially in relation to intranasal use and epinephrine uptake.
EndPoint News, which covers the pharmaceutical industry, reported on Viatris’s petition and concerns. However, it wrote that this was “no surprise,” given that EpiPen is the epinephrine market leader.
Allergic Living asked ARS Pharma’s Lowenthal about Viatris’s call for further study. “We are confident in our data and the neffy registrational program,” he said. The CEO said that program “represents the largest body of research in the epinephrine category.” He also reminds of the advisory committee’s favorable votes following their review of the product’s data.
Lowenthal says ARS Pharma’s data set involves “over 600 persons dosed with neffy and several hundred subjects dosed with three different injection products as comparators, including over 175 with EpiPen.”
He also pointed to a known issue with patient reluctance to use auto-injectors. “An estimated 45 percent of severe allergy patients do not fill their epinephrine prescriptions.”
As ARS awaits the FDA decision, it is working with healthcare providers as well as with insurance payers, and pharmacy benefit managers and retailers. Lowenthal says this is so the company can move quickly “to make this important new treatment modality widely available, should we receive FDA clearance.”