Viatris and Kindeva Drug Delivery have revealed that Mylan Pharmaceuticals, a Viatris subsidiary, has received approval from the U.S. FDA for its abbreviated new drug application (ANDA) for Breyna (budesonide and formoterol fumarate dihydrate inhalation aerosol), the first approved generic version of AstraZeneca’s Symbicort. Breyna, a drug-device combination product, is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD) and will be available in 160 mcg/4.5 mcg and 80 mcg/4.5 mcg dosage strengths.

“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,” said Michael Goettler, CEO, Viatris. “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.”

Headquartered in Woodbury, MN, Kindeva Drug Delivery is a global contract development and manufacturing organization (CDMO) in the pharmaceutical industry, with major R&D and manufacturing sites in the UK at Loughborough and Clitheroe. It focuses on complex drug programs, and its current offering spans inhalation drug delivery, transdermal drug delivery, microneedle transdermal systems and connected drug delivery.

Rajiv Malik, president, Viatris, 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.”

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.

Aaron Mann, CEO, Kindeva Drug Delivery, said, “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.”

The full indication for Breyna includes asthma in patients six years of age and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with COPD, including chronic bronchitis and/or emphysema. COPD is a term used to describe chronic lung diseases 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.