Breyna is said to be the first generic version of AstraZeneca's Symbicort with US Food and Drug Administration (FDA)-approved Abbreviated New Drug Application (ANDA)
Breyna is a generic version of AstraZeneca's Symbicort. (Credit: PR Newswire/ Viatris Inc.)
Healthcare company Viatris and Kindeva Drug Delivery have launched Breyna (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for specific patients with asthma or chronic obstructive pulmonary disease (COPD).
Breyna is said to be the first generic version of AstraZeneca’s Symbicort with US Food and Drug Administration (FDA)-approved Abbreviated New Drug Application (ANDA).
It is a drug-device combination product that is available in both 80 mcg/4.5 mcg and 160 mcg/4.5 mcg dosage strengths.
Viatris North America head Jose Cotarelo said: “We are excited to bring Breyna to the US market for the many Americans living with asthma and COPD. This launch represents years of hard work breaking down barriers to access and builds upon our past successes of bringing other complex products to market as we continue to move up the value chain.
“Being the first to bring an FDA-approved generic version of Symbicort to patients is a true example of how access is the cornerstone of our mission to empower people worldwide to live healthier at every stage of life.”
Breyna is indicated for asthma treatment in patients six years of age and older as well as maintenance treatment of airflow restriction and minimising exacerbations in individuals with COPD, including chronic bronchitis and/or emphysema.
The inhalation aerosol is not recommended for treating severe bronchospasm. The only strength recommended for the treatment of COPD is 160 mcg/4.5 mcg, the healthcare company said.
Kindeva Drug Delivery CEO Milton Boyer said: “The launch of Breyna represents a significant milestone as it is the first FDA-approved generic version of Symbicort in the US, one of the most prescribed complex drug-device combination products to treat asthma and COPD.”
For eligible commercially insured patients, Viatris has launched a copay programme that might assist reduce out-of-pocket costs on prescriptions to as little as $20 per 30-day supply.
The programme, accessible from August, gives $30/month or up to $360/year with 12 refills per year.
Last year, Viatris and Kindeva received US FDA approval for Breyna to treat two pulmonary health conditions.