- Celgene's twice-daily Otezla achieved statistical significance in improving moderate-to-severe scalp psoriasis compared to placebo in a Phase 3 trial, the company announced Wednesday.
- The oral, small-molecule inhibitor of phosphodiesterase 4 also improved whole body itch, a secondary endpoint. Otezla is already approved in the U.S. for active psoriatic arthritis and moderate-to-severe plaque psoriasis in adults.
- Otezla is also in late-stage testing for Behçet’s disease, an inflammatory condition that affects many different parts of the body, such as the mouth, genitals and eyes. Other potential indications include rheumatoid arthritis and asthma.
Uptake for Otezla (apremilast) has been slower than Celgene hoped for.
The Food and Drug Administration first approved the treatment in March 2014 for adults with active psoriatic arthritis, with a follow-up approval in September of that year for adults with moderate-to-severe plaque psoriasis who are also candidates for phototherapy or systemic therapy.
Around the time of launch there were suggestions that Otezla had blockbuster potential. Yet annual net sales of the drug didn't crest over the billion-dollar mark until 2016. For 2018, Celgene is projecting Otezla sales of roughly $1.5 billion — a seemingly fair forecast, given that revenue between January and June totaled $728 million.
Last year, investors were spooked when Celgene scaled back its forecasts for the drug, among other revisions to its long-term guidance.
New indications and data could help Celgene lift Otezla's revenues higher.
The scalp, for instance, is the most commonly affected area in moderate-to-severe plaque psoriasis, and affects up to 80% of people with the skin disorder. It's also an area that is "difficult to treat with topical therapies, and clinical data from systemic therapies are limited," said Terrie Curran, Celgene's president of inflammation and immunology, in an Oct. 8 statement.
Previous results from the Phase 3 ESTEEM 1 trial showed that using Otezla for moderate-to-severe plaque psoriasis led to improvements beyond just skin clearance, including itch and quality-of-life measures, which may have an impact on a patient's disease burden.