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J&J's Tremfya Receives FDA Approval for Psoriatic Arthritis

Johnson & Johnson JNJ announced that the FDA has approved a supplemental biologics license application (sBLA) for its blockbuster IL-23 inhibitor, Tremfya (guselkumab). The sBLA sought label expansion of the drug as a monotherapy or in combination with DMARDs for adult patients with active psoriatic arthritis (PsA).

The sBLA filing was based on data from the pivotal phase III DISCOVER 1 and 2 studies, which evaluated the safety and efficacy of Tremfya compared to placebo for treating adult patients with PsA. The drug is under review in Europe for the same indication.

Please note that Tremfya is the first drug in its category to receive approval for treating PsA in the United States.

J&J’s stock has risen 1.4% this year so far against a decrease of 0.1% recorded by the industry.

Pivotal DISCOVER 1 and 2 studies evaluated the subcutaneous injection of Tremfya in active PsA patients who had inadequate response to standard therapies. Data from both studies showed improvement in a significant number of patients. The proportion of patients receiving Tremfya who showed American College of Rheumatology 20% improvement in DISCOVER 1 study and DISCOVER 2 study were 52% and 64% compared to 22% and 33% for placebo, respectively. Moreover, treatment with Tremfya also led to improvement in fatigue as measured by the Functional Assessment of Chronic Illness Therapy – Fatigue.

Tremfya was first approved in the United States and the EU in 2017 for the treatment of moderate-to-severe plaque psoriasis and was off to a solid start after its launch. The drug recorded sales of $296 million in the first quarter of 2020, representing 36.4% year-over-year growth. The label expansion in PsA indication is likely to boost momentum further. The disease is a complex inflammatory disease, which causes pain, stiffness and swelling in and around the joints. The approval has expanded the drug’s eligible patient population.

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Zacks Rank & Stocks to Consider

J&J currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the large-cap pharma sector include Bayer BAYRY, AstraZeneca PLC AZN and Roche RHHBY. While Bayer sports a Zacks Rank #1 (Strong Buy), AstraZeneca and Roche carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Bayer’s earnings estimates have been revised 4.3% upward for 2020 and 4.2% for 2021 over the past 60 days.

AstraZeneca’s earnings estimates have moved 1% north for 2020 and 4.3% for 2021 over the past 60 days. The stock has rallied 8% year to date.

Roche’s earnings estimates have moved 0.8% north for 2020 and 1.4% for 2021 over the past 60 days. The stock has rallied 8.8% year to date.

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