Fujisawa Healthcare Inc. submitted a new drug application (NDA) for Protopic, a tacrolimus ointment, for the treatment of atopic dermatitis, more commonly known as eczema.
"We completed Phase III trials in March with more than 1,000 patients in the U.S. in more than 40 centers, but we have not released any data from the trials yet," said Maribeth Landwehr, communications associate for the Deerfield, Ill., company. "This is the first new therapy to specifically treat atopic dermatitis in more than 40 years."
Patients in the Phase III trials ranged in age from two to 79, with one-third under the age of 15. In about 20 percent of the patients, the eczema covered or involved more than 75 percent of their bodies.
Protopic was approved in Japan, but has not yet been launched there.
Fujisawa, a subsidiary of Fujisawa Pharmaceutical Co., Ltd., of Osaka, Japan, started enrolling patients in a Phase III study of tacrolimus (Prograf FK506) for rheumatoid arthritis.
"This Phase III trial involves tacrolimus in a capsule form. The NDA we filed today is for tacrolimus in an ointment form for a different indication," Landwehr said.
- Mary Welch