Auvi-Q, an epinephrine auto-injector considered an alternative to the EpiPen, will be reintroduced in the U.S. market in early 2017, according to its manufacturer. The auto-injectors are used to stop potentially life-threatening allergic reactions by administering a dose of the hormone epinephrine. A major U.S. recall of Auvi-Q happened in October 2015, with then-manufacturer Sanofi saying the device may not deliver enough medication to someone with a severe reaction.
The pharmaceutical company Kaleo said Wednesday it has regained the rights to Auvi-Q and will reintroduce the injectors in the first half of 2017. The company said it conducted a "thorough manufacturing assessment and invested in new technology and quality systems." "As the inventors of Auvi-Q, my brother and I have dedicated our lives to researching and developing an innovative epinephrine auto-injector that would do for severe allergy sufferers what the AEDs did for cardiac arrest," says Evan Edwards, Kaleo's vice president of product development and industrialization, in the company's statement.
Auvi-Q has a voice prompt system that guides users through the injection process, as well as a needle that automatically retracts following injection, the company says. "In emergencies such as anaphylaxis, it is often individuals without medical training who need to step in," according to the Kaleo statement. Auvi-Q does not need to seek new approval from the FDA, according to Spencer Williamson, Kaleo president and CEO.
Mylan, the company that manufacturers EpiPens, recently drew criticism from lawmakers and parents of allergic children after news that the company had increased the price by more than 480 percent since 2009. EpiPens can cost as much as $ 700 for a pack of two auto injectors before insurance. Mylan responded to the criticism by saying it would offer a savings card to cover up to $ 300 in costs for the two-pack. It also said it would expand eligibility for its patient assistance program. However, experts said such actions do little to address the problem of high drug prices. Insurance companies still pay most of the wholesale drug cost, and patients may face higher insurance costs as a result.
Kaleo did not offer information on how much Auvi-Q would cost, but said it is committed to affordability. "Our goal is that any patient, regardless of insurance coverage, should have options when it comes to epinephrine auto-injectors, including the option to access Auvi-Q at an affordable price," the company says on Auvi-Q's website. At the time of the October 2015 recall, Auvi-Q cost about $ 400 per set.
Dr. Kenneth Backman of Allergy & Asthma Care comments: "Epinephrine auto-injectors are life-saving, medically necessary devices for patients with life-threatening allergies, such as to food or insect stings. The return of Auvi-Q to the market will offer another option to our patients, and we hope that it will be reasonably priced and readily available. The design of the Auvi-Q was preferred by many patients, and we look forward to the opportunity to prescribe it again soon."