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Pfizer Inc. announced Tuesday that a drug discovered and developed at its Groton laboratories has proven effective enough against plaque psoriasis that it plans to formally request regulatory approval for the remedy next year.
Pfizer said results from two late-stage trials of tofacitinib, which has been approved by the U.S. Food and Drug Administration under the name Xeljanz as a treatment for rheumatoid arthritis, show that the drug greatly reduces psoriasis outbreaks. Earlier studies, however, had shown mixed results, with the most effective psoriasis dosage set higher than was approved for treatment of rheumatoid arthritis - leading to questions about whether the FDA would likely approve tofacitinib due to safety concerns at the higher dose.
The New York-based drug giant, which employs more than 3,000 at its Groton labs, said it plans to submit a supplemental New Drug Application allowing the marketing of twice-daily doses of tofacitinib to treat adults with moderate to severe plaque psoriasis, the most common form of the disease. Chronic plaque psoriasis, which is estimated to affect 7.4 million people in the United States, is identified by the painful red patches that occur most frequently on knees, elbows, the scalp and lower back.
"Psoriasis is a long-term disease with no cure that can have a significant impact on patients," Steven Romano, global medicines development lead for Pfizer, said in a statement. "Many psoriasis patients remain untreated, undertreated or dissatisfied with their treatment."
Tofacitinib came out of work at the local labs that originated in the mid-1990s. Former Pfizer scientist Paul Changelian, in a casual conversation with a scientist from the National Institutes of Health, heard about an enzyme that led to overactive immune responses in people with rheumatoid arthritis and psoriasis, and set about finding a drug to counteract its effects.
Changelian's work became known internally as the JAK project, because the enzyme's discovery came after studying children who had a defect in their JAK3 genes. It would take nearly two decades to discover tofacitinib and bring it to market, and by the time Xeljanz was on pharmacy shelves Changelian was no longer with the company.
Pfizer representatives, in an interview with The Day in 2012, said they studied 400,000 possible compounds and synthesized about 1,000 of them before they came up with an effective and safe treatment. Xeljanz, which some analysts had predicted would become a $2 billion-a-year drug for Pfizer, had only $46 million in worldwide sales last year as its faced stiff competition from established rheumatoid arthritis treatments as well as cheaper generics.
Pfizer's stock finished the day at $31 a share, up about half a percent.
Tuesday's announcement about tofacitinib's effectiveness against psoriasis noted that late-stage clinical studies showed the drug at 5 mg and 10 mg doses showed statistically significant superiority to a placebo in resulting in at least a 75 percent reduction in psoriasis outbreaks and severity. No new safety problems for the drug were noted, Pfizer said.
Pfizer said that in recently published surveys, about half of psoriasis patients are unhappy with current treatments.