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FDA approves Boehringer COPD spray Striverdi Respimat

Licence from US regulator will also allow it to treat chronic bronchitis or emphysema

Boehringer Ingelheim 

Boehringer Ingelheim's once-daily chronic obstructive pulmonary disease (COPD) spray Striverdi Respimat (olodaterol) has won a US licence.

The FDA said it can now be used to treat COPD patients, including those with chronic bronchitis or emphysema to help unblock airways, but the regulator wants the drug to carry warnings against its use in asthma.

In trials, olodaterol delivered improvements in lung function, as measured by forced expiratory volume in one second (FEV1), in patients with moderate to very severe COPD compared to placebo and also active comparators.

As a long-acting beta-adrenergic agonist (LABA) Striverdi Respimat will, in common with other drugs in that class, have to carry a boxed warning that they increase the risk of asthma-related death.

The drug works by helping the muscles around the airways in the lungs stay relaxed to prevent symptoms, but should not be used as a rescue therapy in cases of sudden breathing problems.

Boehringer hopes Striverdi might be a long-term successor to Spiriva (tiotropium), which is marketed with Pfizer and brought in $5bn last year, behind GlaxoSmithKline's $8bn brand Advair/Seretide (fluticasone and salmeterol).

Spiriva is due to lose patent protection soon, and Boehringer is looking at a once-daily combination of olodaterol and tiotropium as a possible means of extending the life of the franchise.

The company has reported positive late stage data, which demonstrated the combination was more effective in improving lung function in COPD patients than placebo or either of the two drugs given as a monotherapy over a six-week period.

But there is a lot of potential competition in COPD at present, including Novartis' QVA149 (glycopyrronium bromide and indacaterol maleate) and GSK and Theravance's Anoro (umeclidinium bromide and vilanterol).

Meanwhile Almirall, whose respiratory franchise is to be bought by AstraZeneca in a $2bn deal, has its own COPD combination - aclidinium bromide/formoterol candidate - in phase III with Forest Labs.

4th August 2014

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