Viatris Inc. (NASDAQ: VTRS):BreynaTM (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, the first generic version of Symbicort® approved by the U.S. Food and Drug Administration (FDA), has been made available by Viatris Inc., a multinational healthcare company, and Kindeva Drug Delivery L.P. Breyna, a drug-device combination product, will be readily available in dosage strengths of 80 mcg/4.5 mcg and 160 mcg/4.5 mcg and is approved for some patients with asthma or chronic obstructive pulmonary disease (COPD).
Viatris Head of North America Jose Cotarelo said: “We are excited to bring Breyna to the U.S. 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 the maintenance treatment of airflow restriction and minimising exacerbations in individuals with COPD, including chronic bronchitis and/or emphysema, in patients six years of age and older. Breyna is not recommended for treating severe bronchospasm. The only strength recommended for the treatment of COPD is 160 mcg/4.5 mcg. More than 16 million Americans suffer from COPD, a specific type of chronic lung disease that is characterised by dyspnea. About 25 million Americans suffer from the chronic disease asthma, which results in airway swelling and breathing difficulties.
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. We are pleased for Viatris as well as the many Kindeva colleagues who have worked tirelessly to leverage our complex drug-delivery expertise for this important respiratory product — supporting a persistent need to continue bringing more quality medicines for asthma and COPD to patients.”
For qualified commercially insured patients, Viatris has launched a copay programme that might assist lower out-of-pocket costs on prescriptions to as little as $20 per 30-day supply. This will help to further increase access to Breyna. With 12 refills per year, the programme gives $30/month or up to $360/year. In August, the programme will be accessible.
About Breyna:
Breyna is prescribed to treat asthma in patients aged 6 and older whose condition has not been adequately controlled by a long-term asthma medication like an inhaled corticosteroid (ICS) or whose condition requires the start of treatment with both an ICS and long-acting beta2-adrenergic agonists (LABA). Breyna 160 mcg/4.5 mcg dosage is recommended for the maintenance treatment of airflow restriction in individuals with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, as well as for lowering COPD exacerbations. Breyna is NOT recommended for treating severe bronchospasm.
