Pfizer's new rheumatoid arthritis(RA) drug XELJANZ(R) has gotten FDA approval for adults with moderate to severe RA who had a poor response to methotrexate.It is the first RA treatment approved in a new class of medicines called JAK inhibitors,and the first new oral disease-modifying anti-rheumatic drug(DMARD) approved in more than 10 years.
The new pill was approved for a 5mg twice daily dosage.It may be used alone or in combination with methotrexate or other non-biologic DMARDs.
Xeljanz is a second-line medication,meaning that pre-treatment with a biologic is not required.It is an important new option that could potentially change the way rheumatologists treat this serious autoimmune disease,according to Pfizer CEO Ian Read.The discovery and development of Xeljanz by Pfizer scientists reflects our commitment to R and D innovation and our dedication to bringing important and meaningful medications to patients.
Xeljanz is specifically designed to inhibit JAK pathways,which are signaling pathways within the cell that play an important role in RA inflammation.Many patients do not adequately respond to,or are intolerant of,currently available RA treatments,said Stanley Cohen,MD,study investigator.Xeljanz significantly reduced the signs and symptoms of RA and improved physical function.
Possible side affects include increased risk of certain infections and cancers,as the drug changes the way the immune system works.
Pfizer(PFE)
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