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Sanofi gets OK for first voice-guided injection device

Chalks up pharma industry first following FDA approval for Auvi-Q

Sanofi chalked up an industry first this week as the US FDA approved its voice-guided epinephrine auto-injector - Auvi-Q - for the treatment of life-threatening allergic reactions.

Auvi-Q features audio and visual cues to guide the person delivering the shot through the injection process, which Sanofi believes could make a real difference in terms of saving the life of a patient undergoing anaphylaxis.

When a severe, life-threatening allergic reaction occurs, epinephrine should be administered immediately, but a study by the National Institutes of Health looking at cases of allergic food reactions in children showed that in up to 70 per cent of anaphylaxis cases an epinephrine injection was not given. 

Reasons cited included fear or anxiety by the person caring for the patient about administering the dose correctly, according to the study, which was published in the journal Paediatrics.

Sanofi concurred with that view, noting other surveys revealed that two-thirds of patients and caregivers do not carry their epinephrine auto-injectors as recommended while nearly half worry that others will not know how to use their device during an emergency.

To overcome this, Auvi-Q talks the user through each step of the injection process - repeating instructions if the caregiver needs more time - and provides a five-second injection countdown and an alert light to signal when the injection is complete. It also features a retractable needle to prevent accidental stick injuries.

"The first step in preventing a severe allergic reaction is always avoidance of the specific allergen," commented Dr Vivian Hernandez-Trujillo, a paediatric allergist and US expert in anaphylaxis. 

"However, in the event of a life-threatening allergic reaction, it's important to know how to respond quickly [and] Auvi-Q offers patients and caregivers guidance through the injection process."

Auvi-Q will enter a market dominated (and arguably almost synonymous with) Mylan's EpiPen auto-injector, which is the leading product in the generic company's specialty product division. EpiPen helped drive the division's sales to $360m in the first half of this year, a rise of 51 per cent attributed mainly to volume and pricing increases for the auto-injector product.

Mylan said shortly after the news of Auvi-Q's approval that it would donate free EpiPens to school across the US.

15th August 2012

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