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J&J (JNJ) Gets FDA Nod for Psoriasis Drug — Guselkumab

Johnson & Johnson JNJ, a healthcare bellwether, announced that the FDA has approved its pipeline candidate guselkumab for the treatment of moderate-to-severe plaque psoriasis. The drug will be marketed by the trade name of Tremfya.

The drug was approved under an accelerated process, following the filing of a priority voucher by J&J.

J&J’s shares have gained 14.4% so far this year, significantly ahead of the 11.3% increase witnessed by the Zacks classified Large-Cap Pharma industry.

Coming back to the latest news, the FDA approval was based on three studies – phase III VOYAGE 1, VOYAGE 2 and NAVIGATE – evaluating the efficacy and safety of guselkumab, an anti-IL-23 human monoclonal antibody, administered by subcutaneous injection for the treatment of adults with moderate-to-severe plaque psoriasis.

Data from the VOYAGE 2 trial (n=992), announced earlier, had showed that significantly higher proportions of patients with moderate-to-severe plaque psoriasis treated with guselkumab achieved high rates of skin clearance compared to those receiving placebo. Around 70% of the patients receiving guselkumab achieved at least 90% clearer skin versus 2.4% on placebo.

The VOYAGE 2 trial evaluated guselkumab versus AbbVie, Inc.’s ABBV Humira. The study demonstrated the statistically significant efficacy of guselkumab compared to Humira at week 16, which was maintained through 24 weeks of treatment. Almost 46.8% of the patients treated with Humira achieved at least 90% clearer skin versus 70% for guselkumab.

The NAVIGATE (n=871) study evaluated the efficacy and safety of switching to guselkumab in moderate-to-severe plaque psoriasis patients who were not achieving clear or almost clear skin with J&J’s other plaque psoriasis medicine Stelara. Data from the study showed that patients who switched to guselkumab showed significantly greater improvements in skin clearance compared with patients who continued to receive Stelara.

Per the company’s press release, around 7.5 million Americans suffer from this disease in which an overproduction of skin cells can cause itching, pain, burning sensation and skin tightness. Hence, an approval of guselkumab has given the company access to a wide patient population in the U.S.

Guselkumab is under review in the EU and Japan for the plaque psoriasis indication. A phase III head-to-head study of Tremfya against Novartis AG’s NVS Cosentyx for moderate-to-severe plaque psoriasis is ongoing. Meanwhile, a phase II trial evaluating guselkumab in moderate-to-severely active psoriatic arthritis is also ongoing.

J&J had previously mentioned that Tremfya has blockbuster potential and could rake in sales of more than $1 billion. Other than Tremfya, J&J expects another key pipeline candidate, sirukumab for rheumatoid arthritis to also gain FDA approval this year. Sirukumab is also under review in the U.S. and EU.

J&J carries a Zacks Rank #3 (Hold). A better-ranked stock in the same space is AstraZeneca plc AZN, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Shares of AstraZeneca have rallied 18.5% so far this year. Also, its earnings estimates for 2017 moved up 0.5%, while the same for 2018 climbed 3.3% in the last 60 days. Its earnings performance has been pretty impressive as well, with consistent positive surprises. The company delivered an average earnings beat of 142.6% in the last four quarters.

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