FDA panel supports approval of Spiriva Respimat

SILVER SPRING, MD. – The majority of a Food and Drug Administration advisory panel supported the approval of an inhaled liquid spray formulation of tiotropium bromide in a new delivery device for the long-term maintenance of chronic obstructive pulmonary disease.

At a Aug. 14 meeting of the FDA Pulmonary-Allergy Drugs Advisory Committee, the panel voted 10-3 that the safety and efficacy data supported the approval of tiotropium bromide inhalation spray, at a dose of 5 mcg/day, administered via a device that contains 30 doses, for the long-term, once-daily maintenance treatment of bronchospasm associated with COPD and for reducing COPD exacerbations.

The panel unanimously voted that the available data supported the efficacy of the device for the indication. This is the same indication approved for the dry powder formulation of tiotropium in the single dose, breath-actuated device, marketed as Spiriva HandiHaler by Boehringer Ingelheim, approved in 2004 by the FDA.

The Respimat device delivers 5-mcg dose and the HandiHaler device delivers 18-mcg dose, with similar pharmacokinetic effects and systemic exposure, according to the company.

Those voting in favor of approval were reassured by the results of a large safety study that addressed concerns about a cardiovascular mortality signal in earlier studies associated with tiotropium Respimat. Boehringer Ingelheim filed for approval of tiotropium Respimat almost 7 years ago; at that time, the FDA requested more data from the company to support the exacerbation claim and to address the mortality imbalance among those treated with tiotropium Respimat in 48-week placebo-controlled studies, and concerns over cardiovascular safety raised during the review.

The safety study of more than 17,000 patients with COPD followed for at least 2 years adjudicated the cause of deaths, comparing 2.5 mg and 5 mg of tiotropium in the Respimat device to the tiotropium HandiHaler device. All-cause mortality in the three groups was similar. There were more fatal MIs in the Respimat-treated patients, but panelists said that this could be a statistical finding and was not strong enough to vote against approval. Some panelists cited lingering concerns about a cardiovascular safety signal in different studies.

If approved, Boehringer Ingelheim plans to market the product as Spiriva Respimat.

The FDA is expected to make a decision on approval by Sept. 21. The agency usually follows the recommendations of its advisory panels. Panel members had no relevant conflicts of interest to disclose.

[email protected]

SILVER SPRING, MD. – The majority of a Food and Drug Administration advisory panel supported the approval of an inhaled liquid spray formulation of tiotropium bromide in a new delivery device for the long-term maintenance of chronic obstructive pulmonary disease.

At a Aug. 14 meeting of the FDA Pulmonary-Allergy Drugs Advisory Committee, the panel voted 10-3 that the safety and efficacy data supported the approval of tiotropium bromide inhalation spray, at a dose of 5 mcg/day, administered via a device that contains 30 doses, for the long-term, once-daily maintenance treatment of bronchospasm associated with COPD and for reducing COPD exacerbations.

The panel unanimously voted that the available data supported the efficacy of the device for the indication. This is the same indication approved for the dry powder formulation of tiotropium in the single dose, breath-actuated device, marketed as Spiriva HandiHaler by Boehringer Ingelheim, approved in 2004 by the FDA.

The Respimat device delivers 5-mcg dose and the HandiHaler device delivers 18-mcg dose, with similar pharmacokinetic effects and systemic exposure, according to the company.

Those voting in favor of approval were reassured by the results of a large safety study that addressed concerns about a cardiovascular mortality signal in earlier studies associated with tiotropium Respimat. Boehringer Ingelheim filed for approval of tiotropium Respimat almost 7 years ago; at that time, the FDA requested more data from the company to support the exacerbation claim and to address the mortality imbalance among those treated with tiotropium Respimat in 48-week placebo-controlled studies, and concerns over cardiovascular safety raised during the review.

The safety study of more than 17,000 patients with COPD followed for at least 2 years adjudicated the cause of deaths, comparing 2.5 mg and 5 mg of tiotropium in the Respimat device to the tiotropium HandiHaler device. All-cause mortality in the three groups was similar. There were more fatal MIs in the Respimat-treated patients, but panelists said that this could be a statistical finding and was not strong enough to vote against approval. Some panelists cited lingering concerns about a cardiovascular safety signal in different studies.

If approved, Boehringer Ingelheim plans to market the product as Spiriva Respimat.

The FDA is expected to make a decision on approval by Sept. 21. The agency usually follows the recommendations of its advisory panels. Panel members had no relevant conflicts of interest to disclose.

[email protected]

SILVER SPRING, MD. – The majority of a Food and Drug Administration advisory panel supported the approval of an inhaled liquid spray formulation of tiotropium bromide in a new delivery device for the long-term maintenance of chronic obstructive pulmonary disease.

At a Aug. 14 meeting of the FDA Pulmonary-Allergy Drugs Advisory Committee, the panel voted 10-3 that the safety and efficacy data supported the approval of tiotropium bromide inhalation spray, at a dose of 5 mcg/day, administered via a device that contains 30 doses, for the long-term, once-daily maintenance treatment of bronchospasm associated with COPD and for reducing COPD exacerbations.

The panel unanimously voted that the available data supported the efficacy of the device for the indication. This is the same indication approved for the dry powder formulation of tiotropium in the single dose, breath-actuated device, marketed as Spiriva HandiHaler by Boehringer Ingelheim, approved in 2004 by the FDA.

The Respimat device delivers 5-mcg dose and the HandiHaler device delivers 18-mcg dose, with similar pharmacokinetic effects and systemic exposure, according to the company.

Those voting in favor of approval were reassured by the results of a large safety study that addressed concerns about a cardiovascular mortality signal in earlier studies associated with tiotropium Respimat. Boehringer Ingelheim filed for approval of tiotropium Respimat almost 7 years ago; at that time, the FDA requested more data from the company to support the exacerbation claim and to address the mortality imbalance among those treated with tiotropium Respimat in 48-week placebo-controlled studies, and concerns over cardiovascular safety raised during the review.

The safety study of more than 17,000 patients with COPD followed for at least 2 years adjudicated the cause of deaths, comparing 2.5 mg and 5 mg of tiotropium in the Respimat device to the tiotropium HandiHaler device. All-cause mortality in the three groups was similar. There were more fatal MIs in the Respimat-treated patients, but panelists said that this could be a statistical finding and was not strong enough to vote against approval. Some panelists cited lingering concerns about a cardiovascular safety signal in different studies.

If approved, Boehringer Ingelheim plans to market the product as Spiriva Respimat.

The FDA is expected to make a decision on approval by Sept. 21. The agency usually follows the recommendations of its advisory panels. Panel members had no relevant conflicts of interest to disclose.

[email protected]