Teva Gets EU Green Light For Reslizumab
Teva is set to get its severe asthma treatment Cinqaero onto the EU market following a positive opinion from the CHMP but, as in the US, its label will restrict its use to adult patients.
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UK HTA body NICE has called for clarifications and updated analyses in draft guidance on Teva’s MAb biologic Cinqaero, a decision that may give heart to potential competitors in the race to dominate the eosinophilic asthma market.
Teva Pharmaceutical Industries Ltd. gained US approval on March 23 to market Cinqair (reslizumab) as an add-on maintenance treatment for adults 18 years or older with severe asthma with an eosinophilic phenotype.
Roche/Genentech's IL-13 inhibiting investigational severe asthma product lebrikizumab has failed in one of its two pivotal trials, adding to reservations about its future. Lebrikizumab is already trailing other biological competitors to the market and the lack of robust data at Phase III could well spell the end in this indication.