Pfizer Inc's experimental drug to treat patients with moderate-to-severe atopic dermatitis met the main goals of improving symptoms in adult patients compared to a rival treatment from Regeneron Pharmaceutical Inc.
The head-to-head study showed Pfizer's abrocitinib was statistically superior compared to Regeneron's dupilumab in each evaluated efficacy measure in the late-stage trial, Pfizer said in a statement on Monday.
Regeneron's dupilumab, sold under brand name Dupixent, is approved for use in adults in the United States, Europe, Japan and also in children aged 6-11 with moderate-to-severe atopic dermatitis. The drug brought in sales of $1.5 billion in the second quarter ended June 30.
The study was designed to directly compare the efficacy of 200 milligram dose of abrocitinib versus 300 milligram dose of dupilumab in adult patients, Pfizer said.
In April, the U.S. Food and Drug Administration extended the review of abrocitinib, pushing the decision on the treatment to the third quarter of this year.
The drug is a JAK inhibitor, a promising class of treatments that target a range of autoimmune diseases that have, however, recently come under the scanner over safety concerns.
Pfizer said a larger percentage of patients treated with abrocitinib experienced adverse events compared to Regeneron's dupilumab. Two deaths occurred in study patients, but were unrelated to its drug, Pfizer said.
Separately, Regeneron and partner Sanofi said on Monday Dupixent significantly reduced overall disease severity and improved skin clearance in a late-stage trial in children aged six months to five years.
Shares of Pfizer were down about 1% in early trading.