Federal health regulators have declined to approve a nasal spray called Neffy that was developed as an alternative to injections for treatment of severe allergic reactions, prompting an appeal by the product's manufacturer and an outcry by an advocacy group for people with life-threatening allergies.
'We Are Very Surprised'The FDA's notification came by way of a Complete Response Letter (CRL) to the drugmaker's new drug application for the Neffy epinepherine nasal spray, with the federal regulator demanding additional testing.
ARS' application for approval was based on clinical trials in healthy patients and those experiencing mild symptoms from a rhinitis attack, with the spray showing a comparable response to injectable medicines.
The company did not, however, test the product on people suffering from anaphylaxis, which is a severe, life-threatening allergic reaction, due to ethical and safety concerns.
ARS said it was caught off guard by the FDA's request because an advisory panel for the agency recommended in May that the nasal spray be approved without the need for additional studies demonstrating its efficacy or safety.
“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," Richard Lowenthal, the company’s chief executive, said in a statement.
Mr. Lowenthal added that the FDA and ARS were previously aligned that the additional study could be carried out as a post-marketing commitment, meaning after the product was approved for sale to the public.
Advisory Panel Gave Neffy Green LightThe nasal spray passed muster at a recent meeting of the FDA’s Pulmonary-Allergy Drugs advisory committee (PADAC), though some members raised concerns that clinical trials were conducted on healthy people or those with mild symptoms rather than individuals suffering from severe allergic reactions.
After weighing data from clinical trials of Neffy on over 600 individuals, the 22-member advisory panel ultimately voted 16–2 to recommend approval.
But the FDA's advisory committee votes aren't an automatic blueprint for approval, a fact borne out by the agency's request to ARS for more pre-marketing tests before getting a green light.
The FDA's letter requests the completion of a study assessing repeat doses of neffy compared to repeat doses of an epinephrine injection product under allergen-induced allergic rhinitis conditions.
These refer to nasal inflammation and symptoms triggered by exposure to allergens, such as dust mites, pollen, or pet dander.
Mr. Lowenthal said the company plans to appeal the FDA's latest decision and resubmit a new application in the first half of 2024.
Advocates for people with allergies expressed frustration with the FDA's move.
Asked for comment, an FDA spokesperson told The Epoch Times in an emailed statement that it cannot disclose the details of existing or potential applications.
However, the spokesperson added that, as a general matter, the FDA sends such letters to applications like ARS if the agency decides not to approve a new drug for a number of reasons including "deficiency in product quality, insufficient information to determine the product is safe for use under the conditions in its proposed labeling, or lack of substantial evidence that the drug product will have the effect it purports to have under the conditions in its proposed labeling."
"The FDA remains committed to the integrity of our drug approval process. Drugs must undergo a rigorous evaluation of safety, quality, and effectiveness before they can be approved," the spokesperson added.
The ARS product is one of several needle-free devices that are under development for the treatment of dangerous reactions to food, insect stings, and medications.
A needle-free device like Neffy could alter treatment for what the Food Allergy Research & Education organization estimates is roughly 33 million Americans with life-threatening allergies to food and other triggers.
The group said many such people eagerly await an alternative to injectables.
"For 36 years, the food allergy community’s only treatment option has been to forcefully insert a needle from an epinephrine auto-injector into the thigh of the patient," Ms. Poblete said.