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.

The EU approvals committee has recommended Teva Pharmaceutical Industries Ltd.'s humanized interleukin-5 antagonist monoclonal antibody, Cinqaero (reslizumab), for use as an add-on therapy in adult patients with severe eosinophilic asthma, whose disease has been inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

This is in line with the label granted by the US FDA in March to the product as Cinqair, which is narrower than that for its first-in-class rival, GlaxoSmithKline PLC's Nucala (mepolizumab) in that market (Also see "Teva's Cinqair OK'd, But Narrower Use Than GSK's Nucala" - Scrip, 24 March, 2016.)

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