Boehringer’s Striverdi gains FDA approval
pharmafile | August 1, 2014 | News story | Sales and Marketing | Advair, COPD, Pfizer, Spiriva, asthma, olodaterol
Boehringer Ingelheim’s new lung drug Striverdi has gained US approval for patients with chronic obstructive pulmonary disorder.
Striverdi Respimat (olodaterol), which comes as an inhalation spray, is now licensed to treat patients with COPD, including chronic bronchitis and/or emphysema, who are experiencing airflow obstruction.
COPD is a serious lung disease that makes breathing difficult and worsens over time and symptoms can include wheezing, cough, chest tightness, and shortness of breath. Cigarette smoking is the leading cause of the disease.
According to the National Heart, Lung, and Blood Institute, COPD is the third leading cause of death in the United States.
“The availability of this new long-term maintenance medication provides an additional treatment options for the millions of Americans who suffer with COPD,” says Curtis Rosebraugh, director of the office of drug evaluation at the FDA.
Striverdi is a long-acting beta-adrenergic agonist (LABA) that helps the muscles around the airways in the lungs stay relaxed to prevent symptoms. The approval is based on recent late-stage data that showed people who received the drug showed improved lung function when compared to placebo.
The drug does however carry a ‘boxed warning’ as it is part of the LABA groups of medicines which can increase the risk of asthma-related death.
It is set up as the next gen version of its ageing COPD drug Spiriva, which BI markets with Pfizer, and brings in around $5 billion a year.
But Boehringer competes in a tough market and Spiriva is currently second to GlaxoSmithKline’s $8 billion Advair sales, whilst AstraZeneca, in third place, earns $3.2 billion from its COPD drug Symbicort.
Analysts at Citigroup estimate that the COPD market is likely to swell from $10 billion in 2013 to $14 billion by 2018, helped in part by the arrival of new drugs such as Striverdi, although many of the current blockbusters are soon to face generic competition.
Ben Adams
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