Navigation Links
Psoriasis Drug Raptiva Pulled From U.S. Market
Date:4/8/2009

Drug manufacturer acts after link found to rare brain infection

WEDNESDAY, April 8 (HealthDay News) -- The troubled psoriasis drug Raptiva is being withdrawn from the U.S. market, California-based drug maker Genentech announced Wednesday.

The move comes almost two months after U.S. health officials issued a public health advisory on the drug after confirming a link to a rare, sometimes fatal brain infection.

In a prepared release, Genentech said Wednesday, "Effective immediately, physicians should not issue prescriptions for Raptiva for any new patients and should promptly contact patients currently receiving Raptiva to assess the most appropriate treatment alternatives. Raptiva will no longer be available after June 8, 2009."

Genentech estimated that approximately 2,000 patients in the United States may currently be using Raptiva (efalizumab) for chronic plaque psoriasis. Since it was approved by the U.S. Food and Drug Administration in 2003, approximately 46,000 patients worldwide have been treated with Raptiva, the company said.

"Our decision to remove Raptiva from the market reflects Genentech's commitment to patient safety," said Dr. Hal Barron, Genentech's senior vice president, development and chief medical officer. "Although we believe that many psoriasis patients are benefiting from Raptiva, the balance between benefit and risk in the psoriasis population for which Raptiva was approved has significantly changed."

In February, an FDA advisory noted there had been three deaths of people taking the drug. Two involved people with confirmed cases of a rare brain infection called progressive multifocal leukoencephalopathy (PML). The third death was a person believed to have contracted the brain infection, according to the advisory.

All had been treated with Raptiva for at least three years, and none was taking other immune suppressants.

In its advisory, the FDA said it would study the issue carefully and "strongly recommends that health care professionals carefully monitor patients on Raptiva, as well as those who have discontinued the drug, for any signs or symptoms of neurologic disease, and that they periodically reassess the benefits of continued treatment."

"Patients should be aware of the symptoms of PML and contact their health care professionals immediately if they experience any such symptoms," the advisory recommended.

Outside experts, however, said at the time that, though the news was serious, there was no reason to panic.

"Patients should talk to their doctors and carefully weigh the risks and benefits of Raptiva, taking into account the most recent bit of information," said Bruce Bebo Jr., director of research for the National Psoriasis Foundation in Portland, Ore.

Srikanth Kolluru, an assistant professor of pharmaceutical sciences at Texas A&M Health Science Center, said that people "who are on this medication currently should be made aware that it might cause brain infection [PML] or any other infections and possible symptoms so that they can contact their physician immediately."

People using the drug "need to be well-informed about the symptoms for PML infection and need to be monitored closely," he said.

Raptiva, a once-weekly injection, suppresses the immune system to reduce psoriasis flare-ups, but this can increase the risk of serious infections and malignancies, experts noted. PML is caused by a virus.

Psoriasis is an autoimmune disease that usually shows up on the skin and can also manifest as psoriatic arthritis, according to the National Psoriasis Association.

Genentech said Wednesday that it was working with Merck Serono, its licensee outside the United States and Japan, to inform other regulatory authorities of the drug's withdrawal from the U.S. market.

More information

Here's more on the FDA health advisory on Raptiva.



SOURCES: April 8, 2009, news release, Genentech, San Francisco; Srikanth Kolluru, Ph.D., assistant professor, pharmaceutical sciences, Irma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Kingsville, Texas; Bruce Bebo Jr., Ph.D., director, research, National Psoriasis Foundation, Portland, Ore.; Feb. 19, 2009, statement, U.S. Food and Drug Administration


'/>"/>
Copyright©2009 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Low-Dose Acitretin May Reduce Nail Psoriasis
2. BioTrends Prepares to Field ChartTrends(TM) Reports to Cover the Use of Biologic Agents in Psoriasis and Rheumatoid Arthritis
3. LeAnn Rimes Shares Her Personal Struggle With Psoriasis in Nations Capital
4. Study Shows Nonprescription LCD Topical Solution is More Effective than Prescription-Strength Calcipotriol Cream for Moderate Plaque Psoriasis
5. American Academy of Dermatology Issues New Guidelines For The Management of Psoriasis With Topical Therapies
6. FDA Warns Users on Psoriasis Drug
7. Psoriasis Cure Now launches StimulateResearch.com to Ensure That Medical Research is Part of Stimulus Bill
8. Galderma Wins FDA Approval for Vectical(TM) Ointment, a Novel Topical Therapy for Mild-to-Moderate Plaque Psoriasis
9. Gene Insights May Improve Psoriasis Care
10. Scientists unmask genetic markers associated with psoriasis
11. An Oral Agent for the Treatment of Moderate to Severe Psoriasis Would Earn a Higher Patient Share in the United States than in Europe
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Psoriasis Drug Raptiva Pulled From U.S. Market
(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding emergency ... its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. Ogunleye ... M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. Ogunleye ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson has ... he has implemented orthobiologic procedures as a method for treating his patients. The ... first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits ... terms of the latter, setting the bar too high can result in disappointment, perhaps ... slow progress toward their goal. , Research from PsychTests.com reveals that ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may ... to unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To ... for healthy coping following a traumatic event. , Trauma sufferers tend to feel a ...
(Date:6/24/2016)... ... ... a crisis. Her son James, eight, was out of control. Prone to extreme mood shifts ... upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a knife ... and say he was going to kill them. If we were driving on the ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... DUBLIN , June 24, 2016 ... "The World Market for Companion Diagnostic Tests" report to ... World Market for Companion Diagnostics The World ... diagnostic and personalized medicine diagnostics. Market analysis in the report ... Diagnostics Test Market (In Vitro Diagnostic Kits) by Region (N. ...
(Date:6/24/2016)... 2016  Arkis BioSciences, a leading innovator in ... durable cerebrospinal fluid treatments, today announced it has ... is led by Innova Memphis, followed by Angel ... investors.  Arkis, new financing will accelerate the commercialization ... release of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... the "Pharmaceutical Excipients Market by Type (Organic Chemical ... Preservative), Formulation (Oral, Topical, Coating, Parenteral) - Global Forecast ... The global pharmaceutical excipients ... 2021 at a CAGR of 6.1% in the forecast ...
Breaking Medicine Technology: