Teva Pharmaceuticals announced it has received opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for marketing authorization of its treatment DuoResp® Spiromax® (budesonide & formoterol fumarate dihydrate) inhalation powder. The company said the positive CHMP opinion paves the ground for a final approval decision from the European Commission expected in the following months.
The company applied for the approval of DuoResp® Spiromax® in patients with asthma and chronic obstructive pulmonary disease (COPD) when a combination inhaled corticosteroid and long-acting beta2-adrenoceptor agonist is indicated. DuoResp Spiromax is a novel multi-dose dry-powder inhaler with a combination of budesonide and formoterol fumarate dehydrate. Budesonide is an inhaled corticosteroid used to treat underlying inflammation in both asthma and COPD. Formoterol fumarate dehydrate is a rapid-acting and long-lasting beta2 agonist used to induce relief of bronchoconstriction in both conditions.
Asthma affects 30 million people in Europe alone with approximately 82,000 cases requiring hospital admissions every year, costing up to €33.9 billion. COPD afflicts 23 million in Europe with 1.1 million hospital admissions recorded annually. Estimated indirect and direct cost of COPD is at €48.4 billion. One of the causes of additional clinic visits and emergency care is poor inhaler technique available to patients. The company said it developed DuoResp Spiromax to address the need for convenience and consistent delivery of drugs to patients. The Spiromax inhaler utilizes unique breath-actuated technology to administer consistent dose of the drug from the first dose to the last.
Rob Koremans, M.D., president and CEO, Teva Global Specialty Medicines, said, “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… we look forward to receiving the final decision from the European Commission.”
Michael Hayden, Teva president and Global R&D and Chief Scientific Officer, said, “We have 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.” The company said it plans to submit application for its new treatment in several major countries worldwide.