Reminyl Receives FDA approval

02-Mar-2001

Shire Pharmaceuticals Group plc (LSE: SHP.L, NASDAQ: SHPGY) announces that Reminyl® (galantamine hydrobromide), a new treatment for mild to moderate Alzheimer's disease, developed by the Janssen Research Foundation and Shire under a co-development and licensing agreement, was approved today by the US food and Drug Administration (FDA). Janssen Pharmaceutica and Ortho-McNeil Pharmaceutical will be marketing Reminyl in the US and intend to make the product available on prescription in May 2001.

Marketing approvals have been received in 21 other countries to date, including most major European markets. Outside of the US Reminyl will be marketed by Janssen-Ortho in Canada (approval pending) and Janssen-Cilag elsewhere, with the exception of the United Kingdom and Ireland, where it is registered and marketed by Shire under a co-promotion agreement with Janssen-Cilag.

It is estimated that Alzheimer’s disease affects some 8 million people in the US and Western Europe. Initially symptoms are mild with gradual memory loss, confusion and disorientation. As the disease progresses it changes the personality, intellect and the ability of an individual to carry out normal daily activities, until eventually it causes death.

“Alzheimer's patients progressively deteriorate," says Gary Small, MD, director of the Center on Aging and professor of psychiatry and behavioral sciences at the University of California in Los Angeles. "But the studies show that Reminyl can be beneficial to many individuals with the disease. In studies lasting up to six months, patients’ symptoms initially may improve or stabilize, and even when they begin to decline, they remain better than those who were treated with placebo."

Dr Wilson Totten, Shire’s Group R&D Director, added “We are delighted that American patients will now be able to benefit from treatment with Reminyl, which we believe to represent an important addition to the treatment options for Alzheimer’s patients.”

https://www.chemeurope.com/en/news/1632/reminyl-receives-fda-approval.html