Viatris launces Breyna, FDA-approved aerosol asthma inhaler

Written on: July 31, 2023 by SprayTM

Viatris, a global healthcare company, and Kindeva Drug Delivery, have collaborated on the launch of Breyna (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, the first generic version of  Symbicort with an Abbreviated New Drug Application (ANDA) approved by the U.S. Food and Drug Administration (FDA).

Breyna, a drug-device combination product, is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD) and will be immediately available in both 80 mcg/4.5 mcg and 160 mcg/4.5 mcg dosage strengths.

Jose Cotarelo, Viatris Head of North America, said, “We are excited to bring Breyna to the U.S. market for the many Americans living with asthma and COPD.”

The indications for Breyna include asthma in patients six years of age and older, and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with COPD, including chronic bronchitis and/or emphysema. Breyna is not indicated for the relief of acute bronchospasm. The 160 mcg/4.5 mcg is the only strength indicated for the treatment of COPD. COPD is a term used to describe a certain kind of chronic lung disease and is characterized by breathlessness; it affects more than 16 million Americans. Asthma causes swelling of the airways resulting in difficulty breathing, and approximately 25 million Americans have the chronic condition.

Milton Boyer, CEO of Kindeva Drug Delivery, added, “The launch of Breyna represents a significant milestone as it is the first FDA-approved generic version of Symbicort in the U.S., one of the most prescribed complex drug-device combination products to treat asthma and COPD.”

To further expand access to Breyna, Viatris has established a copay program offered for eligible commercially-insured patients, which may help reduce out-of-pocket expenses on prescriptions to as little as $20 per 30-day supply. The program offers $30/month or up to $360 per year with 12 refills annually. The program will be available in August.