最近勃林格殷格翰公司又收获了一项利好消息，FDA下属的肺部过敏药物咨询委员会（PADAC）以10票赞成，3票反对的绝对多数通过了勃林格殷格翰公司开发的治疗慢性阻塞性肺炎（COPD）的吸入式药物Spiriva Respimat。如果这一药物最终获得FDA的上市批准，今后临床上，患者们将又多一种吸入式干粉药物的选择。这种药物的活性成分为噻托溴铵，与勃林格殷格翰公司此前已经上市的治疗COPD的药物Spiriva HandiHaler相同。不过Respimat相对于后者来说输送噻托溴铵粉吸入剂更为平缓。此前先行审核中，FDA的专家已经对Respimat减缓COPD患者支气管痉挛和急性加重的整张表示赞同，同时又以9:4的结果通过了其安全性的考量。这对勃林格殷格翰公司的Spiriva Respimat来说是一个重大进步。因为2007年，FDA以缺少药物副作用以及药效相关数据为由否决了这一身轻。此次，勃林格殷格翰公司耗时数年，完成了一项有17135名患者参与的临床试验后再次卷土重来，有极大希望得偿所愿。因为一般而言，FDA不会推翻此前其下属委员会的结论。
勃林格殷格翰公司的Dr. Sabine Luik表示，他们对PADAC的这一决定表示喜悦。勃林格殷格翰公司在过去十几年中一直致力于开发有效的COPD药物以减轻患者痛苦。Spiriva Respimat的获批将能够为这些患者提供新的选择。
详细英文报道：
The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 10-3 to recommend approval of Boehringer Ingelheim's mist formulation of its dry-powder inhalable treatment for chronic obstructive pulmonary disease (COPD). If approved, the new product, Spiriva Respimat, would give clinicians an alternative to the company's FDA-approved tiotropium bromide inhalable dry powder, the Spiriva HandiHaler.
The candidate's active ingredient, tiotropium bromide, is the same as that used in the Spiriva HandiHaler, but the Respimat delivers tiotropium bromide as a slow-moving mist via the Respimat Soft Mist Inhaler, Boehringer Ingelheim says.
"We are pleased with the endorsement from PADAC members, and recommendation of approval for tiotropium Respimat in the U.S.," Dr. Sabine Luik, senior vice president of medicine and regulatory affairs, said in a statement. "At Boehringer Ingelheim, we have been committed to discovering and developing new treatments to help people affected by COPD for several decades. If approved, tiotropium Respimat would build upon our heritage in treating respiratory diseases by equipping healthcare providers and their patients with an important new treatment option."
The panel voted unanimously that the candidate is effective in reducing bronchospasm and exacerbations of COPD, and voted 9-4 that the drug has no significant risk of all-cause mortality, according to MedPage Today. Data from the Tiospir trial showing that patients in the mist arm were at a slightly higher risk of cardiac disorder led to the dissent on that question.
The product was rejected in 2007 due to safety concerns and lack of evidence of efficacy. This time around, Boehringer Ingelheim says the Tiospir trial of 17,135 patients shows that the mist formulation is comparable to the Spiriva HandiHaler on both counts. The trial's lead investigator, Dr. Robert Wise of Johns Hopkins University, told the panel that the mist formulation could benefit newly diagnosed patients, those with poor manual dexterity and patients with weak inhalations because they may find it easier to use than the dry-powder counterpart, MedPage Today reports.
The FDA is not obligated to follow the panel's recommendation but usually does so. The mist formulation is already approved in more than 80 countries around the world.
The alternative delivery method is clearly a "cover all of the bases" play given the lack of clinical proof of superior efficacy and safety over the Spiriva HandiHaler. Following now-likely approval, it will be worth inspecting the labeling's details, such as the mist's side effects, to see if they give doctors any additional incentives to choose Spiriva Respimat over the dry-powder formulation of tiotropium bromide for the treatment of COPD.
In July, the FDA approved another Boehringer Ingelheim COPD treatment, the once-a-day inhaler Striverdi Respimat.