The US FDA has issued a warning letter to Sunovion regarding claims made in four patient brochures aimed respectively at COPD patients currently using MDIs, DPIs, nebulized short acting beta agonists, or any medication giving insufficient control. According to the FDA, the brochures overstate the efficacy of Sunovion’s Brovana arformoterol tartrate inhalation solution and understate the risks.
One of the claims included in the brochures, according to the letter, was that COPD patients could “get back into daily living.” The FDA letter states that, “Although Brovana may improve patients’ mean FEV1, we are not aware of substantial evidence or substantial clinical experience demonstrating that the magnitude of the effect the drug has on FEV1 taken together with any drug-related side effects . . . results in an overall positive impact on patients’ ability to resume their baseline activities of daily living.”
The FDA also objects to implications that patients would find Brovana easier to use than an inhaler, writing that claims “regarding the potential difficulty patients may encounter depressing an inhaler to administer therapy (e.g. “My hands don’t move as well anymore, so it’s hard for me to use my inhaler.”) are misleading because they imply that patients with compromised manual dexterity will more easily be able to administer Brovana as compared to other COPD inhaler therapies.” The letter points out that the instructions for use of Brovana involve tasks such as opening a foil pouch and connecting nebulizer tubing.
The letter gives Sunovion until November 7, 2013 to respond.
Read the FDA warning letter.
