Coming soon to a screen near you: more psoriasis advertisements.
On Thursday, FDA approved the new plaque psoriasis contender guselkumab (Tremfya), from Johnson & Johnson’s Janssen Biotech. It’s the latest drug to win approval for the relatively common autoimmune disease that has made huge strides in the era of biologics.
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Analysts are expecting the drug to claim blockbuster status in the coming years, but there will no doubt be some elbows flying as Big Pharma competes for market share.
Other recent approvals include Cosentyx (Novartis), Taltz (Eli Lilly), and Siliq (Valeant). All three target a pro-inflammatory cytokine called interluekin-17. Guselkumab, on the other hand, blocks interluekin-23 (IL-23), giving it a valuable point of differentiation among this new generation of drugs.
In a January report, life science commercial intelligence firm Evaluate Pharma projected guselkumab sales could reach $1.2 billion by 2022, making it the sixth most lucrative biologic expected to launch in 2017. By mid-year, Evaluate’s sales estimates had risen to $1.6 billion – as noted in its World Preview 2017 Report – following better-than-expected data readouts in the interim months.
More than 2,000 patients were treated with the human monoclonal antibody in three Phase 3 studies; VOYAGE 1, VOYAGE 2 and NAVIGATE. For those receiving the drug, seven out of 10 achieved a 90 percent or greater improvement in skin clearance by week 16. For responders, the effects appeared durable: A majority of those patients had similar disease control at 28 and 48 weeks.
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Perhaps the greatest indication of J&J’s belief in the drug is that it chose to cash in a priority review voucher, thereby expediting the approval process. The team has also hit the ground running from a strategic standpoint, with a plan to offer a co-pay card to patients with commercial insurance, limiting their out-of-pocket expense to no more than $5 per injection. (The drug is administered via subcutaneous injection every eight weeks after an initial two doses in the first four weeks.)
Guselkumab may claim additional indications in the coming years, including for psoriatic arthritis — a related condition that affects the skin as well as the joints. Janssen is also recruiting for two Phase 3 trials in generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP), and palmoplantar pustulosis.
Across the pond, European regulators are reviewing J&J’s initial application in moderate-to-severe plaque psoriasis.
Photo: juststock, Getty Images
