The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday issued a positive opinion recommending approval of Teva's generic version of AstraZeneca's Symbicort (budesonide/formoterol). If approved, the product will be marketed by the Israeli drugmaker as DuoResp Spiromax and BiResp Spiromax for the treatment of appropriate adults with asthma and chronic obstructive pulmonary disease (COPD).
Teva said it also plans to submit the therapy, which is delivered via the Spiromax multi-dose dry-powder inhaler, for regulatory approval in other major markets worldwide. Michael Hayden, the company's chief scientific officer, remarked "we have planned for strong growth in respiratory," adding that "the Spiromax inhaler is an important addition to our...portfolio and supports our strategy to become a leading presence in respiratory with a robust and differentiated pipeline."
According to Teva, two ongoing Phase III studies comparing the benefits of DuoResp to Symbicort in patients with persistent asthma are expected to complete in 2014. The company noted that the trials are not required for final approval in Europe.
Symbicort, which generated sales of $3.5 billion in 2013, is facing competition from GlaxoSmithKline's Breo Ellipta (fluticasone/vilanterol) following approval last year in the US and Europe, as well as generic versions of Advair (fluticasone/salmeterol). Earlier this week, the CHMP recommended approval of another potential competitor, GlaxoSmithKline and Theravance's COPD drug Anoro Ellipta (umeclidinium/vilanterol), which was cleared by the FDA and Health Canada in December.
For further information on the COPD market, see Chronic Obstructive Pulmonary Disorder (COPD) - KOL Insight and Consensus Outlook.
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