Kaléo to Reintroduce AUVI-Q to US Market

Kaléo announced on Oct. 26, 2016 that the company will reintroduce the AUVI-Q (epinephrine injection) to the United States market during the first half of 2017. AUVI-Q is a prescription epinephrine autoinjector used to treat anaphylaxis. The autoinjector includes an automatically retractable needle and a voice prompt system that guides the user through delivery.

In 2015, Sanofi Pasteur issued a voluntary recall of AUVI-Q after the autoinjector was found to potentially have inaccurate dosage delivery. A safety notification from FDA said that the company received 26 reports of the device malfunctioning, although none of the reports were confirmed at the time.

After regaining the rights to AUVI-Q Kaléo said in a press release that it conducted a thorough manufacturing assessment. The assessment included investing in new quality and technology systems to ensure consistent drug delivery. Kaléo said the autoinjector is manufactured on a fully automated robotic production line.

AUVI-Q is expected to be a direct competitor to Mylan’s EpiPen. Mylan received backlash in September 2016, after members of Congress raised questions over the company’s decision to raise the price of the drug more than 400%. Kaléo said in a statement that it recognizes affordability challenges and that the company was working with stakeholders to ensure patients will have affordable access to the drug.  

Source: Kaléo