WASHINGTON (AP) - An experimental drug from a unit of Johnson & Johnson
appears effective at treating a severe skin disease, though government
regulators said Friday it also could slightly increase cancer risks.
Centocor has asked the Food and Drug Administration to approve its biologic
drug to treat psoriasis, which causes painful, red scales to grow on the skin.
The FDA released its review of the drug, ustekinumab, ahead of a Tuesday meeting
where outside experts will vote on whether it should be approved.
The agency said the injectable drug showed positive results in two
comprehensive studies conducted by the company. However, scientists said the
drug may require labeling to warn doctors of possible carcinogenic risks.
While Horsham, Penn.-based Centocor did not assess those risks in its
application, the FDA said studies in mice suggest the drug could encourage tumor
growth. The agency said it would recommend that information be included in the
drug's labeling if it is approved.
The FDA will seek input from its panelists next week, though it is not
required to follow their advice.
The agency will ask whether patients should be allowed to inject the drug at
home, instead of having their physician do it. The FDA cautioned that permitting
self-injection could lead patients to skip appointments, raising the risk that
problems could go unnoticed.
Panelists are also expected to debate dosing levels for ustekinumab, based
on government briefing documents posted online Friday. The FDA notes that
heavier patients showed greater skin improvement when treated with more
concentrated doses of the drug.
Johnson & Johnson has touted ustekinumab's infrequent dosing -- it can be
given in as few as four injections per year -- as a key advantage over products
already on the market. Another drug the company markets to fight psoriasis
requires at least six doses annually.
Ustekinumab is part of a new class of drugs that fight psoriasis by
targeting two proteins that regulate the body's immune system and are believed
to contribute to the disease.
Despite safety concerns, Cowen and Co. analyst Sara Michelmore expects the
drug to easily win approval because it appears more effective than older
psoriasis drugs. She projects sales could eventually rise to over $500 million
annually.
Johnson & Johnson already markets the drug Remicade in the U.S., which is
approved to fight psoriasis, rheumatoid arthritis and the intestinal disorder
Crohn's Disease. Remicade was the company's third-best selling drug last year,
with revenue of $3.3 billion.
It competes against Abbott Laboratories' Humira and Amgen Inc. and Wyeth's
Enbrel.
Earlier this month, the FDA announced it is investigating whether that class
of drugs increase the risk of certain cancers in children.
Drugs already on the market also carry risks of serious side effects,
including tuberculosis, pneumonia and liver problems, according to their
labeling.
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