Breyna is indicated for asthma patients, aged six years and above, along with maintenance treatment of patients with COPD, including chronic bronchitis and/or emphysema
Viatris Global Headquarters in Pittsburgh, Pennsylvania, US. (Credit: Viatris Inc.)
Viatris and Kindeva Drug Delivery have received the US Food and Drug Administration (FDA) approval for Breyna (budesonide and formoterol fumarate dihydrate) inhalation aerosol to treat two pulmonary health conditions.
Breyna is indicated for asthma patients, aged six years and above, along with maintenance treatment of patients with COPD, including chronic bronchitis and/or emphysema.
It is a generic version of AstraZeneca’s Symbicort, a fixed-dose combination medication used for asthma or chronic obstructive pulmonary disease (COPD).
The drug-device combination product has been developed by Viatris’ subsidiary Mylan, in partnership with Kindeva Drug Delivery, a pharmaceutical CDMO.
Kindeva currently offers inhalation drug delivery, transdermal drug delivery, microneedle transdermal systems, and connected drug delivery solutions.
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.”
With the FDA approval, Breyna becomes the first FDA-approved generic version of Symbicort.
Viatris is expected to roll out Breyna this year, in 160mcg/4.5mcg and 80mcg/45 mcg dosage strengths, subject to upcoming court proceedings.
The company was formed in November 2020, through the merger of generic and speciality pharmaceuticals company Mylan and Pfizer’s business division Upjohn.
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.”
Last month, Indian biopharmaceutical firm Biocon, through its subsidiary Biocon Biologics (BBL), has agreed to acquire Viatris’ biosimilars business for up to $3.3bn.