Pfizer gets FDA OK for new Xeljanz indication
The Food and Drug Administration has approved Pfizer’s Xeljanz/ Xeljanz XR (tofacitinib) for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers.
“We are proud to offer Xeljanz, a treatment option for ankylosing spondylitis that does not require an injection or an infusion, to treat this debilitating and chronic immuno-inflammatory disease,” said Mike Gladstone, global president of inflammation and immunology and Pfizer. “This regulatory approval affirms the clinical value and versatility of Xeljanz, the first and only Janus kinase inhibitor approved for five indications in the United States for the treatment of patients with certain immuno-inflammatory conditions.”
[Read more: Pfizer suing Aurobindo over generic Zeljanz]
“Ankylosing spondylitis, a type of arthritis that causes inflammation in certain parts of the spine, affects more than 350,000 people in the U.S. This disease often occurs in early adulthood and causes pain, swelling and possibly restricted mobility,” said Steven Taylor, executive vice [resident, Mission and Strategic Initiatives of the Arthritis Foundation. “With this approval, physicians and patients now have an additional oral treatment option that can help address this chronic and often progressive disease.”
Xeljanz is the first and only oral JAK inhibitor approved in the United States in five indications. It is indicated in patients who have had an inadequate response or intolerance to one or more TNF blockers: in adults with active AS, adults with moderately to severely active RA, active PsA, moderately to severe active ulcerative colitis and in children two and older with active polyarticular course juvenile idiopathic arthritis.
[Read more: Zydus Cadila gets FDA permission for generic Xeljanz]
Ankylosing Spondylitis is a chronic, inflammatory disease that affects men and women in early adulthood. The onset of symptoms usually occurs before the age of 30 and seldom occur after the age of 45. Symptoms of AS include chronic pain and stiffness in the back and hips for those living with the disease and can negatively impact health-related quality of life. Over time, some patients may experience fusion of the vertebrae in the spinal column.