Amgen’s Blockbuster Skin Drug Wins Expanded Indication
The FDA has approved Amgen’s blockbuster Otezla (apremilast) as a treatment for adults with plaque psoriasis of any severity, making it the first oral therapy cleared for that indication.
Otezla was previously approved by the agency for adults with moderate-to-severe plaque psoriasis, psoriatic arthritis and those with ulcers linked with Behçet’s Disease, a rare disorder causing inflammation in blood vessels.
The drug’s latest approval was supported by data from a 595-person multicenter phase 3 trial in which Otezla reduced plaque psoriasis severity for mild-to-moderate adult patients over 16 weeks of treatment when compared against placebo.
Amgen, which acquired Otezla from Celgene for $13.4 billion in 2019 and reported 2020 sales of $2.2 billion for the drug, plans to keep developing the blockbuster therapy for a range of psoriasis indications, including genital psoriasis, pediatric psoriasis and juvenile psoriatic arthritis.