Amgen and Wyeth respond to FDA’s requirement of stronger warnings on TNF blockers

THOUSAND OAKS, Calif. Two companies that developed a biotech drug for treating autoimmune disorders said the product is safe, after the Food and Drug Administration recently announced a requirement to include its strongest warning on the drugs.

Amgen and Wyeth, which market the drug Enbrel (etanercept), said in a statement Wednesday that believed Enbrel was still a safe and effective treatment for the autoimmune diseases it treats, including juvenile idiopathic arthritis.

On Tuesday, the FDA announced that it would require TNF blockers – a drug class that includes Enbrel – to carry a boxed warning following reports of children and adolescents developing cancer while using the drugs. Other drugs affected by the FDA’s action include Abbott’s Humira (adalimumab), UCB’s Cimzia (certolizumab pegol) and Johnson & Johnson’s Simponi (golimumab).