News from the FDA/CDC

FDA asked to approve add-on drug for eosinophilic COPD



GlaxoSmithKline asked the Food and Drug Administration to approve an interleuklin-5 antagonist as an add-on maintenance therapy for patients with eosinophilic chronic obstructive pulmonary disease (COPD).

The pharmaceutical and health care company is seeking approval of mepolizumab to be used specifically to treat COPD patients with an eosinophilic phenotype. The drug currently is indicated to treat patients aged 12 years or older with severe asthma and asthma with an eosinophilic phenotype and is sold under the name Nucala, according to a GlaxoSmithKline statement issued November 7.

GlaxoSmithKline’s application to the FDA includes phase 3 data from the METREX and METREO studies.

Headache, injection site reaction, back pain, and fatigue are the most common adverse reactions seen in patients who took mepolizumab during clinical trials.

Mepolizumab is not approved for the treatment of COPD anywhere in the world, and GlaxoSmithKline intends to also ask other countries’ regulatory authorities to allow this drug to be sold as a therapy for COPD.

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