Viatris and Kindeva Drug Delivery are introducing Breyna (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, the first generic version of AstraZeneca's Symbicort.
Breyna, a drug-device combination product, is indicated for certain patients with asthma or chronic obstructive pulmonary disease and will be immediately available in both 80 mcg/4.5 mcg and 160 mcg/4.5 mcg dosage strengths.
"We are excited to bring Breyna to the U.S. market for the many Americans living with asthma and COPD," said Jose Cotarelo, head of Viatris North America. "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."
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, 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.
"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," Milton Boyer, CEO of Kindeva Drug Delivery, said. "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."
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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, the company said.