Find Laws Find Lawyers Free Legal Forms USA State Laws
Home » Legal News » Xeljanz Approved for Rheumatoid Arthritis

Xeljanz Approved for Rheumatoid Arthritis

November 07, 2012 07:25pm  
Xeljanz Approved for Rheumatoid Arthritis


On November 6, 2012 the Food and Drug Administration announced the approval of Xeljanz (tofacitinib) for the treatment of moderate and severe rheumatoid arthritis in adults who did not respond or were intolerant to methotrexate.  


Badrul Chowdhury, M.D., Ph.D., stated, “Xeljanz provides a new treatment option for adults suffering from the debilitating disease of RA who have had a poor response to methotrexate.” Chowdhury is the director of the FDA’s Division of Pulmonary, Allergy, and Rheumatology Products.  


The FDA reports that rheumatoid arthritis is an autoimmune disease that causes the immune system to attack otherwise healthy joints and tissues around the joints.  About 1.5 million Americans suffer from the disease.  


The drug was approved before its projected fee goal date of November 21, 2012.  Xeljanz will come in a pill form.  The patient will take the pill twice a day in a hope to block molecules called “Janus kinases” which cause inflammation.  


Side Effects of Xeljanz


During clinical trials, patients taking Xeljanz showed an increased risk of infections and especially opportunistic infections.  These are infections that occur when the immune system is weakened.  The drug can also can an increased chance of tuberculosis, lymphoma, and certain kinds of cancers.  There is an increased chance of high cholesterol and a decrease liver enzymes in blood tests as well.  Check the boxed warning with the drug for more information.  


Because of the long term side effects of Xeljanz, the FDA has announced that it is scheduling a study in the future to look at the effects between different dosages and compare results to patients receiving other kinds of treatment.  


The clinical testing involved a total of seven different clinical trials.  The volunteers all had moderate or severe rheumatoid arthritis, and most saw improvements after taking Xeljanz compared to patients receiving a placebo.  


Source: U.S. Food and Drug Administration
 

Comments

Must Read

Pure Food and Drug Act Pure Food and Drug Act
    PURE FOOD AND DRUG ACT TEXT     What is the Pure Food and Drug Act?     The Pure Food and Drug act of 1906 is a federal law that mandates for the inspection of meat products and forbids the sales, manufacturing or transportation of poisonous patent medicines and adulterated food products.
4 Facts that you Must Know about Drug Possession 4 Facts that you Must Know about Drug Possession
Drug Possession DefinedA charge furnishing details expressing the illegal possession of Drugs may be defined as the unlawful, illicit, and prohibited ownership of Drugs; however, the nature within which the individual suspect in question gained access to the Drugs may also be associated with the investigation.
Prempro Prempro
What is Prempro?     Prempro is a dangerous drug that contains medroxyprogesterone and a combination of conjugated estrogens (a mixture of estrogen hormones).
A Guide to Steroids Charges in the United States A Guide to Steroids Charges in the United States
What are Steroids Charges?Steroids charges are components of the criminal procedure undertaken in order to substantiate an individual suspect’s required appearance within a legal venue subsequent to their arrest for criminal concerning the usage of Steroids.
Amphetamine Amphetamine
What is an Amphetamine?Amphetamines are psycho-stimulant drugs--within the phenethylamine class—that produce increased focus and wakefulness in association with decreased appetite and fatigue.
Tips