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Teva gets EU nod for severe asthma drug Cinqaero

Once-monthly dose able to improve asthma control

Teva building 

Teva's severe asthma drug Cinqaero has become the second IL-5 inhibitor to reach the EU market after winning approval from the European Commission.

Cinqaero (reslizumab) has been cleared for use in combination with other medicines for the maintenance treatment of severe eosinophilic asthma in adults, who have had at least one asthma exacerbation in the prior year.

The EU approval has been granted on the back of the BREATH programme of five placebo-controlled trials, which showed that a once-monthly dose of Cinqaero was able to improve asthma control in people whose disease was inadequately controlled with other therapies.

The new drug will compete with GlaxoSmithKline's already-launched Nucala (mepolizumab) in the EU, opening a new front in a battle that is already seeing the two drugs go head-to-head in the US. Teva's drug was approved by the FDA in March as Cinqair.

Teva's drug is however given by intravenous injection while GSK's can be administered subcutaneously, which some analysts believe will hand a marketing advantage to Nucala in the marketplace. Teva does have a subcutaneous version of its therapy in the pipeline, but this is thought to be at least a couple of years away from approval.

Moreover, Cinqaero is spearheading a push by Teva into the branded respiratory therapy category, a sector in which GSK already holds a dominant position. Some analysts have also suggested that Nucala will claim an advantage as its trials include data showing it can reduce corticosteroid use, something that has not been explicitly demonstrated in Teva's studies.

For its part, Teva maintains that there is room in the market for multiple players. "Severe asthma is a significant health issue in Europe and around the world and, for patients living with a severe form of the condition marked by elevated eosinophils, finding an effective treatment option may be a challenge," said Rob Koremans, chief executive of Teva's global specialty medicines division.

Either way, both Nucala and Cinqaero are expected to face competition from other new biologic therapies in development at AstraZeneca, Sanofi/Regeneron and Roche, all in late-stage testing. 

AZ is developing an IL-5 inhibitor called benralizumab and IL-13 inhibitor tralokinumab, while Sanofi and Regeneron are working on IL-4/IL-13 blocker dupilumab and Roche has IL-13 inhibitor lebrikizumab.

Article by
Phil Taylor

18th August 2016

From: Research, Regulatory

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