Mylan receives FDA nod for first generic of Symbicort

Viatris and Kindeva Drug Delivery announced that Mylan, a Viatris subsidiary, has received the Food and Drug Administration's green light for Breyna, which is the first generic of AstraZeneca’s Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol.

The medication is used for the treatment of two common pulmonary health conditions — asthma in patients aged 6 years old and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks, the company said.

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"Today's approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment," Sally Choe, director of the Office of Generic Drugs in the FDA Center for Drug Evaluation and Research, said. "This reflects the FDA's continued efforts to increase competition and access to quality, safe, effective and affordable medicines for patients and consumers."

Asthma impacts 25 million people, more than five million of whom are children, while COPD afflicts more than 16 million, according to the National Heart, Lung, and Blood Institute. Asthma is a chronic, long-term condition that affects the airways in the lungs, which can be worsened by physical activity and most often starts during childhood. It can cause wheezing (a whistling sound when breathing), shortness of breath and coughing. COPD, which includes emphysema and chronic bronchitis, is a long-term, chronic disease that causes airflow blockage and makes it difficult to breathe.

This drug-device combination product is a metered-dose inhaler, which contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing). Two inhalations, two times a day (usually morning and night, about 12 hours apart), treat both diseases by preventing symptoms, such as wheezing for those with asthma, and by helping with better breathing, for those with COPD. 

Breyna will be available in 160 mcg/4.5 mcg and 80 mcg/4.5 mcg dosage strengths.

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"The FDA final approval of Breyna, the first FDA-approved generic version of Symbicort, is an exciting milestone both for our company and the many patients living with asthma and COPD. Our success with this partnership and approval is yet another proof point of the impact of our Global Healthcare Gateway which enables us to join with Kindeva to provide patients in need with new options," Viatris CEO Michael Goettler, said.

"The momentous FDA final approval of Breyna is further evidence of our well-established development expertise and proven ability to move up the value chain with more complex products by leveraging our robust scientific capabilities to target gaps in healthcare and patient needs. This approval also builds on our past successes of bringing other complex product firsts to market and demonstrates the continued delivery of our strong pipeline." Viatris president Rajiv Malik, said.

This approval presents an opportunity for Viatris to launch Breyna in 2022 as the upcoming court proceedings develop. In December 2021, the U.S. Court of Appeals for the Federal Circuit reversed the infringement judgment against Viatris and ordered the case remanded back to the U.S. District Court for the Northern District of West Virginia for further proceedings, the company said.

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"We are pleased that Viatris has received full FDA approval for this important respiratory product. This important milestone is reflective of our sustained commitment to inhalation and complex drug delivery, from technical formulation, clinical program management and regulatory submission, and I'm grateful to my many Kindeva colleagues for their contributions," Aaron Mann, CEO of Kindeva Drug Delivery, said.