FDA panel questions safety, efficacy data for proposed COPD treatment

fda logo FDA panel questions safety, efficacy data for proposed COPD treatment The Food and Drug Administration (FDA) questioned the validity of an experimental drug for the treatment of chronic obstructive pulmonary disease (COPD), cautioning its panel of advisors that the data is incomplete and may not give a clear picture of efficacy and potential adverse reactions.

The treatment, called Anoro Ellipta, is a combination of two drugs, umeclidinium and vilanterol, neither of which has been approved by the FDA as a single therapy. Anoro Ellipta is manufactured by GlaxoSmithKline and Theravance Inc. The two companies in May had secured FDA approval for another COPD drug, Breo Ellipta, and had hoped to keep the momentum going with its new treatment.

The drug is currently being evaluated by an FDA advisory panel, which is charged with making a recommendation to the FDA whether to approve or reject drugs for marketing in the United States. The FDA is not required to follow the recommendation of its advisory committees, however it usually does.

Concerns with Anoro Ellipta surfaced when the FDA found that among the multiple studies presented by the drug makers, there were no follow-ups with patients after treatment, which would give a more complete safety profile of the drug. Another concern was the high dropout rates – which ranged from 15 to 30 percent – that FDA staffers claimed could skew efficacy data.

The FDA also said that the data presented by the drug companies does not support their claim that Anoro Ellipta reduces the need for rescue medication or improve patients’ quality of life in regard to health.

Source: Law 360