Teva Pharmaceutical Industries Ltd. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for DuoResp Spiromax (budesonide & formoterol fumarate dihydrate) inhalation powder for the treatment of patients with asthma and chronic obstructive pulmonary disease (COPD) when a combination inhaled corticosteroid and long-acting beta2-adrenoceptor agonist is appropriate. This CHMP decision creates a path forward for a final approval decision from the European Commission 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 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 $13.9 billion worldwide, and $4.4 billion within Europe.
“We have planned for strong growth in Respiratory,” said Michael Hayden, president, global R&D and chief scientific officer, “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.”
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, president and CEO, Teva Global Specialty Medicines. “We look forward to receiving the final decision from the European Commission.”
Two late stage trials in patients with persistent asthma are currently ongoing to compare the benefits of DuoResp Spiromax versis 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 European Commission.
COPD affects 23 million people in Europe resulting in 1.1 million hospital admissions annually.
Date: February 21, 2014
Source: Teva
Filed Under: Drug Discovery
