Viatris Announces Receipt of First FDA Approval for Generic Version of Symbicort Inhalation Aerosol in Partnership With Kindeva

Viatris Inc. and Kindeva Drug Delivery L.P. recently announced Mylan Pharmaceuticals Inc., a Viatris subsidiary, has received approval from the US 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.

Viatris CEO Michael Goettler said “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 President Rajiv Malik added  “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 US Court of Appeals for the Federal Circuit reversed the infringement judgment against Viatris and ordered the case remanded back to the US District Court for the Northern District of West Virginia for further proceedings.

Aaron Mann , CEO of 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. 

Viatris Inc. is a new kind of healthcare company, empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020, Viatris brings together scientific, manufacturing and distribution expertise with proven regulatory, medical, and commercial capabilities to deliver high-quality medicines to patients in more than 165 countries and territories. Viatris’ portfolio comprises more than 1,400 approved molecules across a wide range of therapeutic areas, spanning both non-communicable and infectious diseases, including globally recognized brands, complex generic and branded medicines, a portfolio of biosimilars, and a variety of over-the-counter consumer products. With a global workforce of approximately 37,000, Viatris is headquartered in the U.S., with global centers in Pittsburgh, Pennsylvania, Shanghai, China, and Hyderabad, India. For more information, visit viatris.com.

Headquartered in Woodbury, MN, Kindeva Drug Delivery is a leading 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. Kindeva provides unique technologies and quality services to its customers, ranging from formulation and product development to commercial manufacturing. Kindeva focuses on complex drug programs, and its current offering spans inhalation drug delivery, transdermal drug delivery, microneedle transdermal systems, and connected drug delivery. Kindeva employs approximately 1,000 people worldwide. For more information, visit www.kindevadd.com.