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  1. CVM Updates

FDA Approves Aservo EquiHaler (ciclesonide) for Severe Equine Asthma

April 13, 2020

The FDA’s Center for Veterinary Medicine (CVM) has approved Aservo EquiHaler (ciclesonide inhalation spray) for the management of clinical signs associated with severe equine asthma in horses. Aservo EquiHaler has not been evaluated for safety and effectiveness in other equids, such as donkeys or mules.

The disease, which has also been known in the past as heaves, chronic pulmonary obstructive disease (COPD), and recurrent airway obstruction (RAO) or summer pasture-associated obstructive pulmonary disease (SPAOPD), results in the narrowing or obstruction of a horse’s airway passages, causing exercise intolerance, labored breathing at rest, wheezing and coughing. Severe equine asthma is associated with exposure to specific environmental triggers (e.g., dust, hay, etc.), and an affected horse may have a familial history of equine asthma.

Aservo EquiHaler is a non-pressurized metered dose inhaler and drug cartridge combination. The drug cartridge contains an inhalation solution that is dispensed by the inhaler into the horse’s left nostril as a spray. Each inhaler is labeled for 10 days of administration and contains sufficient drug to provide 140 actuations (puffs) to the horse. Once the inhaler has been activated, it must be used within 12 days.

The sponsor evaluated the safety and effectiveness of Aservo EquiHaler in horses with severe equine asthma in a multi-site field study involving 26 veterinary clinics in the United States. The data collected during the field study demonstrated that Aservo EquiHaler, when used according to the label, is safe and effective for management of clinical signs associated with severe equine asthma in horses.

The most common adverse effects found were coughing and nasal discharge. A small number of horses involved in the studies also experienced an elevated level of white blood cells (Leukocytosis and/or neutrophilia), sneezing, nasal irritation or bleeding, and laminitis (a painful inflammatory condition of the horse’s tissues in its hoof).

Aservo EquiHaler is available by a veterinarian’s prescription only because professional expertise is required to properly diagnose severe equine asthma and monitor safe use of the product, including treatment of any adverse reactions.

Aservo EquiHaler is manufactured by Boehringer Ingelheim Animal Health USA, Inc. in Duluth, Georgia.

For more information

Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.