Boehringer's new drug Spiriva Respimat is approved to replace the No
2016-12-14
Boehringer Ingelheim,a specialist in respiratory diseases,developed Spiriva Respimat,a new drug for COPD that was rejected by the FDA in 2007.Subsequently,a large global COPD clinical study was conducted,demonstrating efficacy and safety.Recently,the FDA finally approved Spiriva Respimat,which shares the same composition as Spiriva HandiHaler,the most prescribed drug in the COPD market,but its aerosol formulation offers comfort and convenience advantages that will especially benefit newly diagnosed COPD patients.The industry predicts that Spiriva Respimat will replace Spiriva HandiHaler as the leader in the COPD market and achieve blockbuster sales.
Boehringer Ingelheim today announced that the FDA has approved Spiriva Respimat(tiotropium bromide)inhalation aerosol as a long-term,once-daily maintenance medication for chronic obstructive pulmonary disease(COPD).Treatment of bronchospasm,including chronic bronchitis and emphysema,and reduction of acute exacerbations of COPD.Spiriva Respimat will provide an important treatment option for COPD,especially for newly diagnosed COPD patients.
Spiriva Respimat has the same active ingredient(tiotropium bromide powder inhaler)as the marketed drug Spiriva HandiHaler,which is the top-prescribed COPD maintenance medication in the United States,Boehringer said.The drug will continue to be a treatment option for patients with COPD.The Spiriva Respimat was developed to deliver doses of the drug via a slow-moving aerosol,rather than relying on air to quickly deliver the drug through an inhaler.Boehringer plans to bring Spiriva Respimat to market in January 2015.
The FDA refused to approve Spiriva Respimat in 2007,citing safety concerns and a lack of evidence of efficacy.This time,Boehringer conducted TIOSPIR,the largest clinical study to date in COPD patients,involving 17,135 COPD patients,and the data showed that Spiriva Respimat was as effective as Spiriva HandiHaler.According to the experts of the study,the aerosol formulation of Spiriva Respimat will especially benefit the newly diagnosed COPD population,as compared to the dry powder formulation of Spiriva HandiHaler,the aerosol formulation is more comfortable and convenient.
In August,the FDA's Pulmonary Allergy Drugs Advisory Committee(PADAC)also recommended approval of Spiriva Respimat.The Committee concluded that Spiriva Respimat was effective in reducing bronchospasm and acute exacerbations of COPD with no significant risk of all-cause death.
In July,the FDA also approved Boehringer's other COPD drug,Striverdi Respimat,based on the Respimat aerosol inhaler.
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