Johnson & Johnson (JNJ - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion recommending approval of its pipeline candidate, guselkumab for the treatment of moderate-to-severe plaque psoriasis in the EU.
The drug was approved in the United States in July this year and is marketed by the trade name of Tremfya for the treatment of this immune system related skin disorder. A decision from the European Commission (EC) is expected later this year.
So far this year, J&J’s share price has increased 16.7%, comparing favorably with a gain of 16.4% recorded by the industry it belongs to.
The application in the EU 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) showed that significantly higher proportion 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 - Free Report) blockbuster drug, 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.
Meanwhile, a phase III head-to-head study of Tremfya against Novartis AG’s (NVS - Free Report) Cosentyx for moderate-to-severe plaque psoriasis is ongoing. Also, a phase III study 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.
J&J carries a Zacks Rank #3 (Hold).
Stocks to Consider
A better-ranked biotech stock is Alexion Pharmaceuticals, Inc. (ALXN - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Shares of Alexion have gained 19.9% year to date. The Zacks Consensus Estimate for 2017 and 2018 increased 5.2% and 7.5%, respectively, over the past 60 days.
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