European Commission grants marketing approval for Teva’s DuoResp Spiromax


Teva Pharmaceutical has obtained marketing authorisation approval from European Commission for its DuoResp Spiromax for treatment of patients with asthma and chronic obstructive pulmonary disease (COPD) when a combination inhaled corticosteroid and long-acting beta(2) adrenoceptor agonist is appropriate.

DuoResp Spiromax, a multi-dose dry-powder inhaler, contains a fixed-dose combination of budesonide and formoterol fumarate dehydrate.

Budesonide is an inhaled corticosteroid indicated for the treatment of the underlying inflammation in asthma and COPD.

Formoterol fumarate dehydrate is a rapid-acting and long-lasting beta(2) agonist for the relief of bronchoconstriction in asthma and COPD.

According to Teva, DuoResp Spiromax has been demonstrated to be therapeutically equivalent to the budesonide/formoterol combination.

Teva has designed the Spiromax inhaler by considering patient inhalation challenges not in terms of human error, but as a design problem to be solved. Using a unique technology, the inhaler delivers consistent, effective and accurate dose.

Teva claims that the ease-of-use Spiromax inhaler provides consistent delivery from the first to the last dose with three simple steps, including open, breathe and close.

"This is a major advance in inhalers, the need for more intuitive devices is critical and has been highlighted by healthcare professionals and patient groups."

Teva Global Specialty Medicines president and CEO Dr Rob Koremans said: "This is a major advance in inhalers, the need for more intuitive devices is critical and has been highlighted by healthcare professionals and patient groups.

"It is widely accepted that poor or inadequate inhaler technique not only negatively impacts treatment adherence, but means that patients do not obtain the full benefit from their medication.

"We are extremely proud of Spiromax. Our innovative approach to the development of the product means that it offers the key features required for an ideal inhaler.

"DuoResp Spiromax provides a valuable addition to currently available inhalation devices for the treatment of asthma and COPD. It is the first and important milestone in the rollout of our respiratory portfolio in Europe."

Two European Phase III trials are currently comparing the benefits of DuoResp Spiromax and a budesonide/formoterol multi-dose dry powder inhaler in patients with persistent asthma are ongoing. Results of the two trials are expected to be announced later this year.

In February, The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion recommending marketing authorisation for Teva's DuoResp Spiromax inhalation powder

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