When BMS was eyeing Celgene in 2019, it had a skin problem. Celgene’s top psoriasis drug, Otezla (apremilast), which was raking in $1.6bn a year and growing fast, clashed with one of BMS’ most promising molecules, deucravacitinib.
As it became clear that anti-competition regulators would balk at BMS owning two top oral psoriasis drugs, Celgene put Otezla up for sale, with Amgen snapping it up for $13.2bn.
Two years later, with Otezla sales dipping below predictions, deucravacitinib is closing in on Otezla. BMS has submitted it to both the US and EU regulators based on data from the pivotal phase 3 POETYK-PSO clinical trial programme in moderate to severe plaque psoriasis.
The trial showed the drug offered ‘significant and clinically meaningful improvements in skin clearance, symptom burden and quality of life measures’ compared to Otezla.
This week, the US Food and Drug Administration (FDA) delivered some good news for Amgen, approving Otezla in milder stages of the plaque psoriasis. As such, it is now the first and only oral treatment for adults with plaque psoriasis across all severities, including mild, moderate and severe.
The approval is also very good news for the eight million US psoriasis patients, said Dr Linda Stein Gold, director of Dermatology Clinical Research at Henry Ford Health System, Detroit. “Given that psoriasis is a systemic inflammatory disease, some patients may need more than surface level relief. For the first time, dermatologists can offer patients struggling with plaque psoriasis of any degree an effective oral treatment with an established safety profile.”
125 million people globally have psoriasis, a serious, chronic inflammatory disease that causes raised, red, scaly patches to appear on the skin. Plaque psoriasis is the most common form of the disease, affecting about 80% of patients.
The FDA approval is based on findings from the phase 3 ADVANCE trial, in which five times as many adults with mild to moderate plaque psoriasis who were receiving Otezla achieved the primary endpoint compared to placebo.
“Plaque psoriasis can place a significant burden on the lives of patients, regardless of the severity of skin involvement,” said Dr David Reese, head of R&D at Amgen. “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.
“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 and has no lab monitoring requirement,” said Dr Reese.