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J&J Files sBLA for Tremfya With FDA for Psoriatic Arthritis

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Johnson & Johnson (JNJ - Free Report) submitted a supplemental biologics license application (sBLA) to the FDA, seeking approval to expand the label of itsIL-23 inhibitor Tremfya as a treatment for active psoriatic arthritis (PsA).

The sBLA filing was based on data from the phase III DISCOVER 1 and 2 studies, which evaluated the safety and efficacy of Tremfya compared to placebo for treating adult patients with PsA.

In June, J&J’s subsidiary, Janssen had announced top-line results from the studies, which evaluated Tremfya administered by subcutaneous injection. The studies met the primary endpoint of achieving American College of Rheumatology 20% improvement while the safety profile was consistent with the previous programs on Tremfya/guselkumab.

J&J expects to file a similar regulatory application with the European Medicines Agency by the end of this year.

J&J’s stock has risen 0.4% this year so far against a decrease of 1.9% recorded by the industry.



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 $452 million in the first half of 2019. If approved by the FDA for PsA, Tremfya will be the first IL-23 inhibitor to be approved to treat this complex inflammatory disease, which causes pain, stiffness and swelling in and around the joints. It will expand the drug’s eligible patient population and should boost its sales.

Tremfya has proved its superiority over other drugs in the past. Last December, J&J announced results from a head-to-head phase III ECLIPSE study, which compared Tremfya with Novartis' (NVS - Free Report) psoriasis drug, Cosentyx (secukinumab).

Data from the study showed that after a 48-week treatment, 84.5% of the patients treated with Tremfya achieved 90% improvement in disease symptoms as measured by the Psoriasis Area Severity Index in comparison to 70% achieved by Novartis' Cosentyx.

The drug is also being studied for various other indications including phase IIb/III studies in Crohn’s disease and ulcerative colitis and in a phase II study for hidradenitis suppurativa.

J&J currently has a Zacks Rank #3 (Hold). Some better-ranked large-cap pharma stocks include Roche Holding AG (RHHBY - Free Report) and Merck (MRK - Free Report) , both with a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Shares of Roche have gained 10.8% this year so far. Earnings estimates for 2019 have risen 0.8% while that for 2020 have increased 2% over the past 60 days.

Merck’s stock is up 7.3% this year so far. Its earnings estimates have risen 3.6% for 2019 and 1.3% for 2020 over the past 60 days.

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