Label Expansion: Amgen's Otezla Adds Scalp Data
With FDA approval of a supplemental New Drug Application (sNDA), the label for Amgen's Otezla will now be updated to include scalp psoriasis data from the Phase 3 STYLE trial. The label expansion makes Otezla the only oral treatment option to have data specific to moderate to severe scalp psoriasis in the label.
Estimates suggest that up to 80 percent of patients with plaque psoriasis have scalp involvement. “The scalp is a particularly difficult location to treat as the patient’s hair may act as a barrier to effective treatment with topical or phototherapy options. This label update reinforces the use of Otezla as an oral, non-biologic option that may reduce the severity and itch of scalp psoriasis, in appropriate patients," says Linda Stein Gold, MD, director of Dermatology Clinical Research at Henry Ford Health System in Detroit and STYLE investigator.
"We are excited that healthcare providers are now armed with more treatments to specifically address this tough-to-treat manifestation of psoriasis," notes Stacie Bell, chief scientific and medical officer at the National Psoriasis Foundation.