As Amgen’s Otezla girds for competition against a potentially formidable rival, the company is doing all it can to gain an edge for the plaque psoriasis treatment.
On Monday, Otezla nabbed an FDA approval that expands its use to those who are candidates for phototherapy or systemic therapy. The indication, for the milder version of the disorder, now makes Otezla the only oral treatment sanctioned all severities of plaque psoriasis—mild, moderate and severe. It also brings roughly 1.5 million potential patients into the fold.
Earlier this month, Amgen set itself up for perhaps another FDA nod for Otezla. The company said its treatment was effective against moderate to severe genital psoriasis, a condition which effects up to 63% of psoriasis patients.
The positive developments come as Otezla steels itself for the much-anticipated launch of Bristol Myers Squibb’s TYK2 inhibitor deucravacitinib, expected in the second half of 2022. A recent trial showed deucravacitiinib topped Otezla at clearing skin in moderate to severe plaque psoriasis patients.
In 2019, Celgene sold Otezla to Amgen for $13.4 billion to get antitrust clearance for the company’s $74 billion sale to BMS. Under Amgen’s watch, sales have been stagnant, but this key approval could help stem the tide.
“A substantial unmet need remains for mild to moderate plaque psoriasis patients whom topical therapies may not be sufficient, especially for those with difficult-to-treat areas, like the scalp,” David Reese, Amgen’s R&D chief, said in a 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 worldwide and has no lab monitoring requirement.”
Otezla also boasts approvals for psoriatic arthritis (2014) and for the treatment of ulcers associated with Behcet’s disease (2019).
In the first and second quarter of this year, Otezla’s sales came in at $476 million and $534 million respectively, both down from the same quarters the previous year. But the third quarter saw a rebound as sales improved to $609 million, a 13% bump year-over-year.
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Tuesday’s approval was based on findings from a phase 3 trial in which five times as many adults with mild to moderate plaque psoriasis receiving Otezla twice daily achieved the primary endpoint of static physician’s global assessment response at week 16 compared to placebo.