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Safety Data Inconclusive for Pulmonary Drug Anoro Ellipta

FDA advisors question cardiovascular profile (September 5)

According to a Reuters report, the FDA’s Pulmonary–Allergy Drugs Advisory Committee has ruled that Anoro Ellipta (umeclidinium/vilanterol, GlaxoSmithKline/Theravance), an investigational drug for the treatment of chronic obstructive pulmonary disease (COPD), appears to work, but the safety data are not entirely conclusive.

The committee issued its opinion prior to a meeting scheduled for September 10, during which an outside panel of medical experts will discuss the drug and recommend whether the FDA should approve it. The agency is not required to follow the advice of its expert panels but typically does so.

The advisors said that while the safety database for Anoro Ellipta is fairly large, it is “not entirely conclusive, particularly in regards to cardiovascular safety.”

The total number of major heart-related problems was fairly low, the advisors said, and the drug’s overall cardiovascular safety profile was unremarkable, but imbalances were found when subsets of data were examined, particularly with regard to nonfatal heart attacks.

“Whether these imbalances and discrepancies constitute a safety signal when taken in the context of the complete development program will be a topic for further discussion,” the advisors remarked.

Anoro Ellipta (umeclidinium/vilanterol) is a new combination inhalation product consisting of a long-acting antimuscarinic agent (LAMA) and a long-acting beta-agonist (LABA). The product is supplied as a dry powder inhalation formulation administered by the Ellipta inhaler device.

Currently, no LAMA/LABA combination products are approved for the treatment of COPD in the U.S.

Sources: Reuters; September 5, 2013; and FDA; September 2013.

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