DuoResp Spiromax is indicated for the treatment of COPD patients when a combination inhaled corticosteroid and long-acting beta2-adrenoceptor agonist is appropriate.
The CHMP decision creates a path forward for a final approval decision from the European Commission (EC) that is expected in the next few months.
DuoResp Spiromax is a new multi-dose dry-powder inhaler with a combination of budesonide, an inhaled corticosteroid for the treatment of 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 a different breath-actuated technology to deliver a consistent dose of the medicines from the first dose to the last.
The product was developed to improve ease of use and provide consistent delivery of medicine to patients and it will enter the ICS/LABA fixed combination inhaled market segment that has total product sales of $13.9bn worldwide, and $4.4bn within Europe.
Teva president of Global R&D and chief scientific officer Michael Hayden said the company has planned for strong growth in Respiratory.
"The Spiromax inhaler is an important addition to our Respiratory portfolio and supports our strategy to become a leading presence in Respiratory with a robust and differentiated pipeline, projected to be a multi-billion dollar franchise by the end of the decade," Hayden said.
Apart from the European application, other applications will also be made in several major countries across the world.
Teva president and CEO of Global Specialty Medicines Rob Koremans said that the Committee’s favorable view of the registration dossier for DuoResp Spiromax marks an important step in the company’s journey to deliver a valuable new treatment option for the treatment of patients with asthma and COPD.
"We look forward to receiving the final decision from the European Commission," Koremans said.