Viatris Announces Launch of Breyna™ (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, the First FDA-Approved Generic Version of Symbicort® for People with Asthma and Chronic Obstructive Pulmonary Disease, in Partnership with Kindeva
- None.
- None.
Launch demonstrates companies' commitment to bringing complex generic medicines to the market to help increase patient access
PITTSBURGH and WOODBURY, Minn., July 31, 2023 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, and Kindeva Drug Delivery L.P. today announced the launch of Breyna™ (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, the first generic version of AstraZeneca's Symbicort® with an Abbreviated New Drug Application (ANDA) approved by the
Viatris Head of North America Jose Cotarelo said: "We are excited to bring Breyna to the U.S. market for the many Americans living with asthma and COPD. This launch represents years of hard work breaking down barriers to access and builds upon our past successes of bringing other complex products to market as we continue to move up the value chain. Being the first to bring an FDA-approved generic version of Symbicort to patients is a true example of how access is the cornerstone of our mission to empower people worldwide to live healthier at every stage of life."
The indications for Breyna include asthma in patients six years of age and older, and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with COPD, including chronic bronchitis and/or emphysema. Breyna is not indicated for the relief of acute bronchospasm. The 160 mcg/4.5 mcg is the only strength indicated for the treatment of COPD. COPD is a term used to describe a certain kind of chronic lung disease 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.
Milton Boyer, CEO of Kindeva Drug Delivery, added: "The launch of Breyna represents a significant milestone as it is the first FDA-approved generic version of Symbicort in the
To further expand access to Breyna, Viatris has established a copay program offered for eligible commercially-insured patients, which may help reduce out-of-pocket expenses on prescriptions to as little as
About Breyna
Breyna is indicated for the treatment of asthma in patients 6 years and older not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta2-adrenergic agonists (LABA). Breyna 160 mcg/4.5 mcg dosage is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, and Breyna 160 mcg/4.5 mcg is also indicated to reduce exacerbations of COPD. Breyna is NOT indicated for the relief of acute bronchospasm.
Important Safety Information
Breyna is contraindicated in the primary treatment of status asthmaticus or other acute episode of asthma or COPD where intensive measures are required, and in hypersensitivity to any of the ingredients in Breyna. Use of long-acting beta2-adrenergic agonists (LABA) as monotherapy (without inhaled corticosteroids [ICS]) for asthma is associated with an increased risk of asthma-related death. Available data from controlled clinial trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA. When LABA are used in fixed dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to ICS alone. Breyna is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms. Breyna should not be initiated in patients during rapidly deteriorating episodes of asthma or COPD. Patients who are receiving Breyna should not use additional formoterol or other LABA for any reason. Localized infections of the mouth and pharynx with Candida albicans has occurred in patients treated with Breyna. Patients should rinse the mouth after inhalation of Breyna. Lower respiratory tract infections, including pneumonia, have been reported following the administration of ICS. Due to possible immunosuppression, potential worsening of infections could occur. A more serious or even fatal course of chickenpox or measles can occur in susceptible patients. It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may occur, particularly at higher doses. Particular care is needed for patients who are transferred from systemically active corticosteroids to ICS. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available ICS. Caution should be exercised when considering administration of Breyna in patients on long-term ketoconazole and other known potent CYP3A4 inhibitors. As with other inhaled medications, paradoxical bronchospasm may occur with Breyna. Immediate hypersensitivity reactions may occur, as demonstrated by cases of urticaria, angioedema, rash, and bronchospasm. Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular effects. Breyna should be used with caution in patients with cardiovascular disorders especially coronary insufficiency, cardiac arrhythmias, and hypertension. Long-term use of ICS may result in a decrease in bone mineral density (BMD Assessment of BMD is recommended prior to initiating Breyna and periodically thereafter. ICS may result in a reduction in growth velocity when administered to pediatric patients. Glaucoma, increased intracolular pressure, and cataracts have been reported following the administration of ICS, including budesonide, a component of Breyna. Close monitoring for glaucoma and cataracts is warranted in patients with a change in vision or history of increased intraocular pressure. In rare cases, patients on ICS may present with systemic eosinophilic conditions. Breyna should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines. The most common adverse reactions ≥
About Viatris
Viatris Inc. (NASDAQ: VTRS) is a global 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, and a variety of over-the-counter consumer products. With more than 38,000 colleagues globally, Viatris is headquartered in the
About Kindeva Drug Delivery
Kindeva Drug Delivery is a global contract development manufacturing organization focused on drug-device combination products. Kindeva Drug Delivery develops and manufactures products across a broad range of complex drug-delivery formats, including injectables (autoinjector, intradermal, microneedle), pulmonary & nasal, and transdermal patches. Its service offering spans early-stage feasibility through commercial scale drug product fill-finish, container closure system manufacturing, and drug-device product assembly. Kindeva Drug Delivery serves a global client base from its nine manufacturing and research and development facilities located in the
Forward-Looking Statements
This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward looking statements may include statements that the launch of Breyna demonstrates the companies' commitment to bringing complex generic medicines to the market to help increase patient access; Breyna will be immediately available in both 80 mcg/4.5 mcg and 160 mcg/4.5 mcg dosage strengths; this launch represents years of hard work breaking down barriers to access and builds upon our past successes of bringing other complex products to market as we continue to move up the value chain; to further expand access to Breyna, Viatris has established a copay program offered for eligible commercially-insured patients, which may help reduce out-of-pocket expenses on prescriptions to as little as
View original content to download multimedia:https://www.prnewswire.com/news-releases/viatris-announces-launch-of-breyna-budesonide-and-formoterol-fumarate-dihydrate-inhalation-aerosol-the-first-fda-approved-generic-version-of-symbicort-for-people-with-asthma-and-chronic-obstructive-pulmonary-disease-in-partn-301888925.html
SOURCE Viatris Inc.
FAQ
What is the name of the company launching Breyna?
What is Breyna™?
What is the indication for Breyna?
What is Viatris' copay program for Breyna?
What is the CEO of Kindeva Drug Delivery's comment on the launch of Breyna?