According to Intelliject, Inc., allergic reactions including anaphylaxis will now receive emergency treatments thanks to the US-FDA approval of the company’s New Drug Application (NDA) for E-cue™, which is a novel epinephrine auto-injector.
Intelliject’s vision and ability to execute the development of patient-centric products is corroborated by the provisional approval of E-cue™ following a first cycle, 10-month review by the FDA. President and CEO of Intelliject, Spencer Williamson, said: “E-cue™’s tentative approval is another important step along our journey to empower patients living with serious medical conditions.”
Acquiring a provisional approval is marked by the completion of product review and compliance to FDA’s requirements for submissions. However, until all patent disputes have been resolved, the FDA reserves the right to providing final approval. King Pharmaceuticals, Inc. (King) and Meridian Medical Technologies, Inc. (Meridian) have a brought upon a current patent lawsuit against Intelliject; hence, marketing of E-cue™ in the USA necessitates final FDA approval.
Intelliject is hoping to receive final FDA approval followed by E-cue™’s subsequent availability, as it is confident that pending patent challenges with King and Meridian will be positively resolved.
A severe allergic reaction involving a number of body systems and causing occasional fatality is referred to as Anaphylaxis. Although the accurate incidence of anaphylaxis is unknown and underreported, the American College of Allergy, Asthma, and Immunology, estimates that for every 100,000 people in the US, there are nearly 2,000 incidences of anaphylaxis annually.
People with high sensitivity and allergies to certain foods, insect stings, medications, latex or other allergens are afflicted with anaphylaxis, and epinephrine has been established as the first treatment of choice for an acute episode, according to national anaphylaxis guidelines. Fatalities are most often seen in those individuals who do not receive timely epinephrine treatment.