Amgen and Wyeth comment on TNF blockers

Amgen and Wyeth Pharmaceuticals have responded to the regulatory authorities regarding the safety of tumour necrosis factor (TNF) blockers.

Such drugs on the market include Cimzia (certolizumab pegol), Enbrel (etancercept), Humira (adalimumab) and Remicade (infliximab).

The companies issued a response to the statement from US Food and Drug Administration (FDA) relating to opportunistic fungal infections in patients treated with these compounds.

In this statement the FDA called for specific language relating to histoplasmosis and other such infections on the prescribing information for these drugs to make sure patients contracting these conditions are diagnosed and treated rapidly.

“Amgen and Wyeth are committed to the safety of patients,” the firms said. “Both companies maintain ongoing safety surveillance programs worldwide to analyse and evaluate safety reports from controlled and open-label clinical trials and patient registries.”

They added they would also assess reports from patients and healthcare professionals and work together with regulatory agencies to periodically update the labelling for its compounds based on new information.

In July 2008, Reuters reported that rheumatoid arthritis drug Enbrel had showed “dramatic improvements” in the symptoms of Alzheimer’s disease in a small 12-patients study, with many reporting improved language recall following administration of the compound.