US-based Viatris Inc., (NASDAQ: VTRS) has announced that the US Food and Drug Administration (FDA) has approved the company’s Abbreviated New Drug Application (ANDA) for Breyna (budesonide + formoterol fumarate dihydrate), a generic version of AstraZeneca’s originator product Symbicort. This approval positions Viatris as the first company to offer an FDA-approved generic alternative to Symbicort, expanding treatment options for patients with asthma or chronic obstructive pulmonary disease (COPD).
Breyna’s Indications and Partnership
Breyna, developed in partnership with Kindeva Drug Delivery LP, is a drug and device combination product indicated for use in treating patients with asthma or COPD. It is available in two dosage forms: 80mcg/4.5mcg and 160mcg/4.5mcg. The product can be used to treat asthma in patients aged six years or older and as a maintenance treatment for airflow obstruction and reducing exacerbations in patients with COPD, including chronic bronchitis and/or emphysema. It is important to note that Breyna is not intended for the relief of acute bronchospasm, with the 160 mcg/4.5 mcg form specifically for COPD treatment.
Market Potential and AstraZeneca’s Sales Performance
The market potential for Symbicort is substantial, with an estimated 16 million COPD sufferers and 15 million chronic asthma sufferers in the United States. AstraZeneca reported global sales revenues of USD 1.28 billion for Symbicort during the first half of 2023, demonstrating a 4% year-on-year growth, indicating a strong demand for this class of respiratory medications.-Fineline Info & Tech
