The FDA recently approved Otezla as a treatment for adults with mild to moderate plaque psoriasis who are eligible to receive phototherapy (light treatments) or systemic therapy (medications that travel throughout the bloodstream). The decision was announced on Dec. 20.
This expanded approval is good news for people with milder cases of psoriasis, according to Dr. David M. Reese, executive vice president of research and development at Amgen — the company that makes Otezla.
“A substantial unmet need remains for mild to moderate plaque psoriasis patients for whom topical therapies may not be sufficient, especially for those with difficult-to-treat areas, like the scalp,” said Dr. Reese in a recent press release. “With this expanded indication for Otezla, patients across all levels of disease severity now have an oral, systemic option that has already been used by more than 650,000 people worldwide.”
Otezla’s new approval came after Amgen reported positive results from its phase 3 ADVANCE trial, which measured safety and effectiveness of the drug in people with mild or moderate psoriasis. There have been a few key findings from this trial so far:
This trial also showed that apremilast is safe. Researchers identified a few potential side effects, including headache, nausea, diarrhea, and cold symptoms.