In a letter released on Tuesday, the U.S. Food and Drug Administration (FDA) charges that Sunovion Pharmaceuticals Inc. deceptively promoted its respiratory drug Brovana (arformoterol), minimizing the drug’s risks and exaggerating its effectiveness.
According to the letter, the FDA questioned several statements in Sunovion’s promotional literature, including the claim that Brovana, used to treat chronic obstructive pulmonary disease (COPD), might help patients “get back to daily living,” Law360 reports.
Clinical trials showed Brovana produced a roughly10 percent improvement in the volume of air a patient can exhale during a forced breath, according to Law360. While this improvement is clearly beneficial to the patient, the FDA said there is no solid evidence that Brovana’s positive impact, when taken together with its side effects, will result in an “overall positive impact on patients’ ability to resume their baseline activities of daily living.”
This letter is a milder rebuke than a formal warning letter, Law360 says, but the FDA is concerned that Sunovion, a U.S. division of Japan’s Dainippon Sumitomo Pharma Co. Ltd., created the impression, without supporting clinical trial evidence, that Brovana is superior to other COPD drugs. The FDA highlighted this statement in a brochure as one misleading example: “Do you take your medicine correctly, but still feel like you may need something more?” The FDA also noted another statement that implied the Brovana inhaler might be easier to use for patients with compromised manual dexterity but didn’t provide details about the inhaler’s design.
Further, the FDA chided Sunovion for marketing materials that allegedly didn’t do enough to warn patients of Brovana’s risks, including fatalities involving patients with asthma, chest pain, and sinusitis, according to Law360. The agency criticized Sunovion for typographical design that emphasized benefits with large, boldface type and relegated risks to small, single-spaced type.