miercuri, 27 mai 2009

Ce mai produc americanii pentru psoriazis

LOS ANGELES, May 26 (Reuters) - U.S. regulators have extended for a
second time their review of Johnson & Johnson's (JNJ.N) experimental
psoriasis drug, named Stelara, the company said on Tuesday.

J&J said the deadline for a decision by the Food and Drug
Administration was extended by three months and the agency has
requested no additional clinical trials.

An FDA advisory committee last June recommended that the drug, also
known as ustekinumab, be approved, but the agency said in December
that would hold off on making a decision on the marketing application
until it received certain risk-mitigation information.

J&J said it responded to that request in January.

"We remain focused on collaboration with the FDA and providing the
necessary information to support the review and approval of Stelara
for the treatment of adults with moderate to severe plaque psoriasis,"
Jay Siegel, J&J's chief biotechnology officer, said in a statement.

Psoriasis, a condition in which itchy red plaques accumulate on the
surface of the skin, is caused by an overproduction of skin cells. It
affects an estimated 7.5 million patients in the United States, J&J

Ustekinumab, a monoclonal antibody which was highly effective in
treating psoriasis in clinical trials, is given by infrequent
injections and works by taming two immune system proteins called
interleukin-12 (IL-12) and interleukin-23 (IL-23) that are linked to

It was well tolerated in two large trials, with generally mild side
effects that did not require adjustments in the medicine.

By contrast, current treatments -- including Wyeth's (WYE.N) leading
injectable Enbrel, Abbott Laboratories' (ABT.N) injectable Humira and
J&J's older Remicade medicine that is given
by intravenous infusion -- can increase risk of infection and
reactivate tuberculosis. (Reporting by Deena Beasley

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