In March 2021, the FDA granted tentative approval to Breyna (Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol) — the first generic version of Symbicort. Today, the agency granted approval for the abbreviated new drug application (ANDA) for the drug-device combination product for certain patients with asthma or chronic obstructive pulmonary disease (COPD).
When Breyna received tentative approval, the commercial launch was prevented as a result of ongoing patent litigation after AstraZeneca’s claims over its Symbicort patents. According to today’s news release, the 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 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,” Viatris CEO Michael Goettler said in the release. “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.”
Breyna’s indication includes asthma in patients six years of age and older, as well as the maintenance treatment of airflow obstruction and reducing exacerbations for COPD patients, which include those with chronic bronchitis and/or emphysema.
The offering will be available in 160 mcg/4.5 mcg and 80 mcg/4.5 mcg dosage strengths.
“We are pleased that Viatris has received full FDA approval for this important respiratory product,” Kindeva Drug Delivery CEO Aaron Mann said. “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.”