最近勃林格殷格翰公司又收獲了一項利好消息，FDA下屬的肺部過敏藥物咨詢委員會（PADAC）以10票贊成，3票反對的絕對多數通過了勃林格殷格翰公司開發的治療慢性阻塞性肺炎（COPD）的吸入式藥物Spiriva Respimat。如果這一藥物最終獲得FDA的上市批準，今后臨床上，患者們將又多一種吸入式干粉藥物的選擇。這種藥物的活性成分為噻托溴銨，與勃林格殷格翰公司此前已經上市的治療COPD的藥物Spiriva HandiHaler相同。不過Respimat相對于后者來說輸送噻托溴銨粉吸入劑更為平緩。此前先行審核中，FDA的專家已經對Respimat減緩COPD患者支氣管痙攣和急性加重的整張表示贊同，同時又以9:4的結果通過了其安全性的考量。這對勃林格殷格翰公司的Spiriva Respimat來說是一個重大進步。因為2007年，FDA以缺少藥物副作用以及藥效相關數據為由否決了這一身輕。此次，勃林格殷格翰公司耗時數年，完成了一項有17135名患者參與的臨床試驗后再次卷土重來，有極大希望得償所愿。因為一般而言，FDA不會推翻此前其下屬委員會的結論。
勃林格殷格翰公司的Dr. Sabine Luik表示，他們對PADAC的這一決定表示喜悅。勃林格殷格翰公司在過去十幾年中一直致力于開發有效的COPD藥物以減輕患者痛苦。Spiriva Respimat的獲批將能夠為這些患者提供新的選擇。
詳細英文報道：
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.