Teevee, if you are going to post here....post the whole story not just paragraphs you feel are relevant to whatever purpose you are trying to serve, don't pretend to provide the facts when you are not providing the full information and at least a URL.
As SNRKID has pointed out the FDA has said this new class of drugs theoretically may carry an increasd risk for malignancies and infections. Therefore, long-term risks are not published or known as yet. You conveniently omitted this specifically and a lot of other information which I have posted the full information...
FDA has taken action on safety issues with Remicade...excerpt from FDA and URL. Also in article below J&J has no plans to have ustekinumab in a head-ti-head trial versus Remicade (J&J product).
"Data from clinical trials and post-marketing reports have identified serious adverse events associated with Remicade therapy and these adverse events appear to be related to the effects of the drug. Serious infections, including tuberculosis and opportunistic infections, have been reported. Some of these infections have been fatal.
In clinical trials evaluating the use of Remicade in rheumatoid arthritis and adult Crohn’s disease, there have been more reports of malignancies including a type of malignancy called lymphoma in patients receiving Remicade compared to those receiving placebo.
These risks of malignancy and serious infection have been described in Remicade labeling, and were also the subject of an FDA Arthritis Advisory Committee meeting in March, 2003 (https://www.fda.gov/ohrms/dockets/ac/03/briefing/3930b1.htm).
Other adverse events that can occur with Remicade therapy include allergic or infusion reactions, liver injury, worsening of heart failure, hematologic events, hypersensitivity reactions, and neurologic events"
(Updated to add analyst reaction and stock prices beginning in the eighth paragraph.)
By Peter Loftus
Of DOW JONES NEWSWIRES
Johnson & Johnson (JNJ) said its experimental drug ustekinumab was more effective at treating the skin disease psoriasis than
Amgen Inc.'s (AMGN) and
Wyeth's (WYE) blockbuster drug Enbrel in a J&J-funded patient study.
J&J, New Brunswick, N.J., already has applied for U.S. Food and Drug Administration approval to market
ustekinumab, supported by previous studies in which the drug was shown to be superior to a fake drug in treating
psoriasis. The newest study is unlikely to play a major role in the FDA's impending decision.
The FDA is expected to decide on ustekinumab by December, having extended its review in August to allow more
time to examine amendments to J&J's application. An FDA advisory committee in June recommended the drug be
approved, but the agency isn't bound by the panel's advice. Analysts expect the drug, if approved, to generate
hundreds of millions of dollars in sales within a few years.
The latest data for ustekinumab were presented Thursday at a meeting of dermatologists in Paris.
In the 903-patient trial, participants with moderate to severe psoriasis received one of two dose levels of
ustekinumab or Enbrel. The main goal was to track the proportion of patients in each group who achieved at least
a 75% reduction in psoriasis at 12 weeks, as measured by an index assessing the surface area and severity of the
disease, which causes skin lesions.
J&J said 68% of those taking the lower dose of ustekinumab and 74% taking the higher dose achieved at least a 75% reduction in disease, versus 57% of Enbrel users reaching that mark.
"We've never really seen clearance [of psoriasis] along the lines of what we've seen with ustekinumab," said Alan
Menter, a dermatologist with Baylor Research Institute in Dallas and one of the trial's lead investigators. Menter
said he has conducted research funded by other psoriasis-drug manufacturers including Amgen.
Citigroup analyst Matthew Dodds said previous, separate trials had suggested ustekinumab was superior to
Enbrel, "but this is the first time it has been demonstrated in a single study." Dodds believes the new study,
together with previous studies, "provides a compelling argument for FDA approval."
J&J shares rose 31 cents to $69.82 in recent trading. Amgen was off $2.38, or 3.9%, at $59.35. Shares of
Wyeth
rose 37 cents to $38.17.
Wyeth co-promotes Enbrel with Amgen in the U.S. and Canada, but
Wyeth has exclusive
rights to Enbrel outside those countries.
Amgen spokeswoman Sonia Fiorenza said the study "does not address long-term safety" because it lasted only 12
weeks. She noted Enbrel has a "consistent safety profile" and 16 years of clinical experience.
Wyeth made similar
comments in defense of Enbrel.
The proportion of study participants experiencing at least one side effect was comparable among the treatment
groups. Those experiencing at least one serious adverse event totaled 1.9% among those on the lower dose of
ustekinumab, 1.9% on the higher dose and 1.2% of those taking Enbrel.
A higher proportion of the Enbrel group experienced injection-site problems but that may have been influenced by
the increased frequency of injections. Those taking ustekinumab were injected once at the start of the study and
again at week four, while those on Enbrel received twice-weekly doses for 12 weeks.
Enbrel was introduced in 1998 as a treatment for rheumatoid arthritis. Following regulatory approval for additional
uses including psoriasis, it is now one of the best-selling drugs in the world, racking up $5.3 billion in global sales
last year, according to IMS Health.
The ustekinumab-versus-Enbrel study was the first head-to-head trial of two so-called biologics in psoriasis
treatment, J&J said. A biologic is a drug derived from a living organism and is typically injected or given by
intravenous infusion, in contrast to more traditional pharmaceutical pills taken orally. In addition to Enbrel, other
biologics approved to treat psoriasis include
Astellas Pharma Inc.'s (4503.TO) Amevive, J&J's Remicade,
Abbott
Laboratories' (ABT) Humira and
Genentech Inc.'s (DNA) Raptiva.
J&J said it had no plans to study ustekinumab in head-to-head trials versus Remicade.
Remicade, Enbrel and Humira belong to a class of drugs known as anti-tumor neucrosis factors, or anti-TNFs,
which work by fighting inflammation in various parts of the body. Some also are approved to treat gastrointestinal
disorders. Anti-TNFs are among the biggest-selling drugs, and carry high price tags.
Ustekinumab would be the first of a new class of anti-inflammatory drugs that target proteins called interleukins.
Abbott Labs also is developing an anti-interleukin drug, ABT-874, which is being evaluated in a late-stage study of
psoriasis patients.
The FDA has said this new class of drugs theoretically may carry an increased risk for malignancies and infections
because the drugs suppress the immune system. However, studies so far haven't shown an increased risk of
malignancies, though J&J is monitoring the long-term risk. Infection rates were similar among treatment groups in
the latest study.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289; peter.loftus@dowjones.com
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Dow Jones Newswires
09-18-08 1539ET
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