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|February 21, 2014 7:50 a.m.|
|Teva Receives CHMP Positive Opinion for DuoResp® Spiromax® for the Treatment of Patients Diagnosed with Asthma and COPD in Europe|
Innovative new inhaler for asthma and COPD patients
DuoResp® Spiromax® is a new multi-dose dry-powder inhaler with a combination of budesonide, an inhaled corticosteroid to treat the underlying inflammation in asthma and COPD, and formoterol fumarate dihydrate, a rapid-acting and long-lasting beta2 agonist for the relief of bronchoconstriction in asthma and COPD. The Spiromax® inhaler uses unique breath-actuated technology to deliver a consistent dose of the medicines from the first dose to the last.
DuoResp® Spiromax® was developed to improve ease of use and provide consistent delivery of medicine to patients. Many patients with asthma and COPD are under-treated as a consequence of poor inhaler technique. This leads to unnecessary burden in the form of additional clinic visits and need for emergency care. DuoResp® Spiromax® will enter the ICS/LABA fixed combination inhaled market segment that has total product sales of
“We have planned for strong growth in Respiratory,” said
In addition to the European application, applications will be made in a number of major countries worldwide.
“The Committee’s favorable view of the registration dossier for DuoResp® Spiromax® marks an important step in Teva’s journey to deliver a valuable new treatment option for the treatment of patients with asthma and COPD,” said Rob Koremans, M.D., President and CEO, Teva Global Specialty Medicines. “We look forward to receiving the final decision from the
Two late stage trials in patients with persistent asthma are currently ongoing to compare the benefits of DuoResp® Spiromax® vs Budesonide/Formoterol Multi-dose Dry Powder Inhaler. Both studies are expected to report in 2014 but are not required to be completed to gain final approval from the
COPD affects 23 million people in
ASTHMA: 30 million people across
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