Amgen Inc.’s treatment Otezla was approved by the U.S. Food and Drug Administration to treat adults with all levels of plaque psoriasis.
“With this expanded indication, Otezla is now the first and only oral treatment approved in adult patients with plaque psoriasis across all severities, including mild, moderate and severe,” the Thousand Oaks company said in a statement.
About 8 million people in the U.S. have plaque psoriasis, according to Amgen.
“Plaque psoriasis can place a significant burden on the lives of patients, regardless of the severity of skin involvement,” Dr. David Reese, Amgen’s executive vice president of research and development, said in a statement. “A substantial unmet need remains for mild to moderate plaque psoriasis patients for whom topical therapies may not be sufficient, especially for those with difficult-to-treat areas, like the scalp.”
Otezla has already been used by more than 650,000 people worldwide, according to Reese.
The FDA approval came because of Otezla’s Phase three ADVANCE trial, which was successful in providing significant improvements in key plaque psoriasis symptoms like whole body itch and scalp itch.
Commonly reported side effects such as headache, diarrhea and nausea were reported by less than 5 percent of patients.
“Plaque psoriasis often affects patients more severely than can be measured by Body Surface Area alone, particularly for those with manifestations in difficult-to-treat areas like the scalp,” Stacie Bell, chief scientific and medical officer at the National Psoriasis Foundation, said in a statement. “The location of plaques may make the area sensitive to topical treatments or challenging to apply them.”
The company announced the approval last week. Shares of Amgen (AMGN) closed up $1.38, or a fraction of a percent, to $225.17 on the Nasdaq Monday, a day when the market closed up more than 1 percent.