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Viatris and Kindeva Unveil Breyna™: FDA-Approved Generic Inhalation Aerosol for Asthma and COPD Patients

Monday, July 31, 2023

Viatris Inc. (NASDAQ: VTRS) and Kindeva Drug Delivery L.P. have introduced Breyna™ (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, marking the first generic version of AstraZeneca's Symbicort®. The U.S. Food and Drug Administration (FDA) has approved this Abbreviated New Drug Application (ANDA) for Breyna™. This drug-device combination product is designed for certain patients with asthma or chronic obstructive pulmonary disease (COPD) and will be readily available in two dosage strengths: 80 mcg/4.5 mcg and 160 mcg/4.5 mcg.

Viatris Inc. (NASDAQ: VTRS), along with Kindeva Drug Delivery L.P., has launched Breyna™ (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol in the United States. This marks the first FDA-approved generic version of AstraZeneca's Symbicort®. The product is designed to benefit individuals with asthma and chronic obstructive pulmonary disease (COPD). Jose Cotarelo, Viatris' Head of North America, expressed enthusiasm for bringing Breyna™ to the market, stating that it reflects the company's mission of enhancing access to healthcare and improving people's well-being.

The indications for Breyna™ include treating asthma in patients aged six years and older and managing airflow obstruction while reducing exacerbations in patients with COPD, including chronic bronchitis and emphysema. It's important to note that Breyna™ is not intended for relieving acute bronchospasm. COPD is a chronic lung disease that causes breathlessness and affects over 16 million Americans, while asthma, which affects around 25 million Americans, leads to airway swelling and difficulty breathing.

Milton Boyer, CEO of Kindeva Drug Delivery, also praised the launch of Breyna™, highlighting its significance as the first FDA-approved generic version of Symbicort® in the U.S., a widely prescribed drug-device combination product for asthma and COPD treatment. Kindeva's expertise in complex drug delivery played a crucial role in the development of this respiratory product, underscoring their commitment to providing high-quality medicines for patients with asthma and COPD.

In order to improve access to Breyna™, Viatris has introduced a copay program for eligible commercially-insured patients. The program aims to reduce out-of-pocket expenses, offering prescriptions for as low as $20 per 30-day supply. Starting in August, patients can benefit from up to $30/month or up to $360 per year with 12 refills annually through this copay program.

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