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FDA Approves Ixifi (infliximab-qbtx), a Biosimilar to Remicade

Posted 1 day 9 hours ago by Drugs.com

December 13, 2017 – Pfizer Inc. (NYSE:PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Ixifi (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab)* for all eligible indications of the reference product.1 The FDA has approved Ixifi as a treatment for patients with rheumatoid arthritis, Crohn's disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.1 FDA approval follows the acceptance of the Ixifi Biologics License Application in April 2017 and is based on the totality of evidence demonstrating a high degree of similarity to the reference product, including the REFLECTIONS B537-02 study in patients with moderate to severe active RA2. The Phase 3, multi-national, r ... Read more

Related support groups: Psoriasis, Crohn's Disease, Psoriatic Arthritis, Remicade, Ulcerative Colitis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Plaque Psoriasis, Ulcerative Colitis - Active, Crohn's Disease - Acute, Ulcerative Colitis - Maintenance, Infliximab, Inflectra, Renflexis, Ixifi

FDA Approves Simponi Aria (golimumab) for the Treatment of Adults With Active Psoriatic Arthritis or Active Ankylosing Spondylitis

Posted 26 Oct 2017 by Drugs.com

Horsham, Pa., October 20, 2017 ― Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved Simponi Aria (golimumab), the only fully-human anti-tumor necrosis factor (TNF)-alpha therapy administered via a 30-minute infusion, for the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS). Today’s approvals follow the first FDA approval of Simponi Aria in 2013 for the treatment of moderately to severely active rheumatoid arthritis (RA). The PsA and AS approvals are supported by comprehensive clinical development programs that demonstrated the significant efficacy of Simponi Aria over placebo, while offering a consistent safety profile across all indications. In the study for the treatment of active PsA, patients experienced improvement in joint symptoms and inhibition of structural damage. In the study for t ... Read more

Related support groups: Psoriatic Arthritis, Ankylosing Spondylitis, Simponi, Simponi Aria, Golimumab

FDA Approves Cyltezo (adalimumab-adbm), a Biosimilar to Humira

Posted 30 Aug 2017 by Drugs.com

Ridgefield, Conn., August 29, 2017 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Cyltezo, a biosimilar to Humira, in a pre-filled syringe for the treatment of multiple chronic inflammatory diseases, including: moderate to severe active rheumatoid arthritis moderate to severe polyarticular juvenile idiopathic arthritis** active psoriatic arthritis active ankylosing spondylitis (an arthritis that affects the spine) moderate to severe active adult Crohn’s disease moderate to severe active ulcerative colitis moderate to severe plaque psoriasis “Cyltezo is the first biosimilar from Boehringer Ingelheim to be approved by the FDA and marks an important step towards our goal of providing new and more affordable treatment options to healthcare providers and patients,” said Ivan Blanarik, Senior Vice President and Head of The ... Read more

Related support groups: Rheumatoid Arthritis, Humira, Psoriasis, Crohn's Disease, Psoriatic Arthritis, Ulcerative Colitis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Plaque Psoriasis, Ulcerative Colitis - Active, Crohn's Disease - Acute, Juvenile Rheumatoid Arthritis, Ulcerative Colitis - Maintenance, Juvenile Idiopathic Arthritis, Humira Pen, Adalimumab, Cyltezo, Amjevita

2 of 3 Americans Don't Have 'Advance Directive' for End of Life

Posted 7 Jul 2017 by Drugs.com

FRIDAY, July 7, 2017 – Most people don't like talking about dying, especially their own death. But it's important to let your loved ones know how you'd like your medical care handled when your "time" comes. Yet, new research found that two-thirds of American adults haven't completed an advance directive. That's a legal document that outlines a person's wishes if they become incapacitated and can't make their own health care decisions, particularly near the end of life. "Most experts agree that some form of written directives are a key component of advance care planning, and yet rates of completion are low and do not appear to be increasing," said study leader Dr. Katherine Courtright. She is an instructor at the University of Pennsylvania's Palliative and Advanced Illness Research Center. "We need to address common barriers to completing these important documents on a national level, ... Read more

Related support groups: Cancer, Breast Cancer, Ankylosing Spondylitis, Colorectal Cancer, Breast Cancer, Metastatic, Breast Cancer - Palliative, Gastric Cancer

FDA Approves Renflexis (infliximab-abda), a Biosimilar to Remicade

Posted 27 Apr 2017 by Drugs.com

INCHEON, Korea – April 24, 2017 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Renflexis (infliximab-abda), a biosimilar referencing Remicade®i (infliximab), across all eligible indications. In the US, Renflexis is indicated for reducing signs and symptoms in patients with adult and pediatric Crohn’s disease, adult ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis, and for the treatment of adult plaque psoriasis. Renflexis is the first Samsung Bioepis product approved for marketing in the United States (US). “Since our company was established five years ago, we have strived day in and day out to realize the promise of biosimilars for patients across the United States by offering them treatment options at a lower cost. We hope this regulatory milestone will bring us a step closer to achievin ... Read more

Related support groups: Rheumatoid Arthritis, Crohn's Disease, Psoriatic Arthritis, Remicade, Ulcerative Colitis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Plaque Psoriasis, Ulcerative Colitis - Active, Crohn's Disease - Acute, Ulcerative Colitis - Maintenance, Infliximab, Renflexis

Amjevita Approved to Treat Inflammatory Diseases

Posted 27 Sep 2016 by Drugs.com

MONDAY, Sept. 26, 2016 – Amjevita (adalimumab-atto) – a biosimilar drug similar to the popular anti-inflammatory drug Humira – has been approved by the U.S. Food and Drug Administration. Amjevita has been approved for moderate-to-severe rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis (an arthritis that affects the spine); Crohn's disease; ulcerative colitis; plaque psoriasis and juvenile idiopathic arthritis, the FDA said in a news release. Biological drugs are generally derived from a living organism and can come from many sources, including humans, animals, microorganisms or yeast, the FDA said. A biosimilar drug is a biological product that's sanctioned after its maker proves it is "highly similar" to an already-approved biologic drug. The manufacturer of the biosimilar drug must prove that the product has "no clinically meaningful differences" in safety, purity ... Read more

Related support groups: Rheumatoid Arthritis, Humira, Crohn's Disease, Psoriatic Arthritis, Ulcerative Colitis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Plaque Psoriasis, Ulcerative Colitis - Active, Crohn's Disease - Acute, Ulcerative Colitis - Maintenance, Juvenile Idiopathic Arthritis, Adalimumab, Amjevita

FDA Approves Amjevita (adalimumab-atto), a Biosimilar to Humira

Posted 26 Sep 2016 by Drugs.com

September 23, 2016 – The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases. Amjevita is approved for the following indications in adult patients: moderately to severely active rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis (an arthritis that affects the spine); moderately to severely active Crohn’s disease; moderately to severely active ulcerative colitis; and moderate to severe plaque psoriasis. Amjevita is also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older. Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. “This is the fourth FDA-approved biosimilar. The biosimilar pathway is still a new fr ... Read more

Related support groups: Rheumatoid Arthritis, Humira, Psoriasis, Crohn's Disease, Psoriatic Arthritis, Ulcerative Colitis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Plaque Psoriasis, Ulcerative Colitis - Maintenance, Adalimumab, Amjevita

FDA Approves Erelzi (etanercept-szzs), a Biosimilar to Enbrel

Posted 1 Sep 2016 by Drugs.com

August 30, 2016 – The U.S. Food and Drug Administration today approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998. Erelzi is administered by injection for the treatment of: moderate to severe rheumatoid arthritis, either as a standalone therapy or in combination with methotrexate (MTX); moderate to severe polyarticular juvenile idiopathic arthritis in patients ages two and older; active psoriatic arthritis, including use in combination with MTX in psoriatic arthritis patients who do not respond adequately to MTX alone; active ankylosing spondylitis (an arthritis that affects the spine); and chronic moderate to severe plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy. Health care professionals should review the prescribing ... Read more

Related support groups: Rheumatoid Arthritis, Enbrel, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Juvenile Idiopathic Arthritis, Etanercept, Erelzi

Inflectra Approved as 'Biosimilar' to Remicade

Posted 7 Apr 2016 by Drugs.com

WEDNESDAY, April 6, 2016 – The U.S. Food and Drug Administration has approved its second-ever "biosimilar" drug, Inflectra, for adults with Crohn's disease, rheumatoid arthritis or chronic plaque psoriasis, among other prescribed uses. In a media release, the agency said Inflectra was biosimilar to Janssen Biotech's Remicade (infliximab), first licensed in 1998. A biosimilar drug is sanctioned based on its maker's ability to show that it is "highly similar" to an already-approved biological drug that is generally derived from a living organism, such as a person, animal, microorganism or yeast, the FDA said. The maker of a biosimilar drug also must prove that the product has no "clinically meaningful difference" in safety and effectiveness from the original drug, and that the newer product has only "minor differences in clinically inactive components" from the original. Inflectra's most ... Read more

Related support groups: Rheumatoid Arthritis, Psoriasis, Crohn's Disease, Psoriatic Arthritis, Remicade, Ulcerative Colitis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Plaque Psoriasis, Ulcerative Colitis - Active, Crohn's Disease - Acute, Ulcerative Colitis - Maintenance, Infliximab, Inflectra

FDA Approves Inflectra (infliximab-dyyb) a Biosimilar to Remicade

Posted 7 Apr 2016 by Drugs.com

April 5, 2016 – The U.S. Food and Drug Administration today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA. Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998. Inflectra is approved and can be prescribed by a health care professional for the treatment of: adult patients and pediatric patients (ages six years and older) with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy; adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; patients with moderately to severely active rheumatoid arthritis in combination with methotrexate; patients with active ankylosing spondylitis (arthritis of ... Read more

Related support groups: Rheumatoid Arthritis, Psoriasis, Crohn's Disease, Psoriatic Arthritis, Remicade, Ulcerative Colitis, Ankylosing Spondylitis, Plaque Psoriasis, Infliximab, Inflectra

Novartis Receives FDA Approval for Cosentyx (secukinumab) to Treat Patients with Ankylosing Spondylitis and Psoriatic Arthritis

Posted 17 Jan 2016 by Drugs.com

EAST HANOVER, N.J., Jan. 15, 2016 Novartis announced today that the US Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) for two new indications - the treatment of adult patients with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). AS and PsA are both life-long, painful and debilitating inflammatory diseases that affect the joints and/or spine. If not treated effectively, both conditions can lead to irreversible joint and/or spinal bone damage caused by years of inflammation.2,3,4 With these new approvals, Cosentyx is now the first and only interleukin-17A (IL-17A) antagonist approved for AS, as well as moderate to severe plaque psoriasis and PsA, which impacts as many as 30% of patients with psoriasis.5 Cosentyx was approved for adult patients with moderate to severe plaque psoriasis in January 2015 and more than 13,000 patients with this ... Read more

Related support groups: Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Cosentyx, Secukinumab

New Drug for Severe Form of Arthritis Shows Promise in Trial

Posted 24 Dec 2015 by Drugs.com

WEDNESDAY, Dec. 23, 2015 – A drug recently approved for the skin condition psoriasis may also help people with a debilitating form of arthritis that attacks the spine, a new clinical trial finds. The condition, called ankylosing spondylitis, causes inflammation around the vertebrae, which can lead to chronic pain and stiffness in the back and neck – and, in some people, eventually cause some vertebrae to fuse into an immobile position. In the new trial, researchers found that a drug called secukinumab (Cosentyx) helped control symptoms in 61 percent of spondylitis patients who were given the highest dose. Experts said the results, published Dec. 24 in the New England Journal of Medicine, could open up a new option for managing spondylitis. And new options are needed, said Dr. Scott Zashin, a fellow with the American College of Rheumatology who was not involved in the study. ... Read more

Related support groups: Psoriasis, Ankylosing Spondylitis, Plaque Psoriasis, Cosentyx, Psoriatic Arthropathy

Cimzia Approved by FDA for Treatment of Adults with Active Ankylosing Spondylitis

Posted 23 Oct 2013 by Drugs.com

ATLANTA, Oct. 18, 2013 /PRNewswire/ – regulated information – UCB announced today that the U.S. Food and Drug Administration (FDA) has approved Cimzia® (certolizumab pegol) for the treatment of adults with active ankylosing spondylitis (AS). The FDA also issued a Complete Response Letter relating to the supplemental Biologics License Application (sBLA) of Cimzia® for the treatment of adults with active axial spondyloarthritis (axSpA). UCB is working with the FDA to determine a path forward to bring Cimzia® to US patients living with active axSpA. With these four indications, UCB confirms expected global peak sales for Cimzia of at least €1.5 billion during the second half of the decade. The approval of Cimzia for adults with active AS was based on a Phase 3, multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Cimzia in patien ... Read more

Related support groups: Ankylosing Spondylitis, Cimzia, Certolizumab

Salty Diet Might Help Trigger MS, Rheumatoid Arthritis

Posted 6 Mar 2013 by Drugs.com

WEDNESDAY, March 6 – Eating lots of foods loaded with salt may do more than raise your blood pressure: Researchers report that it could also contribute to the development of autoimmune diseases, where the body's immune system mistakenly mounts an attack upon some part of the body. Three new studies suggest salt may be a prime suspect in a wide range of autoimmune diseases, including multiple sclerosis (MS), psoriasis, rheumatoid arthritis and ankylosing spondylitis (arthritis of the spine). A significant increase in the incidence of autoimmune diseases, especially multiple sclerosis and type 1 diabetes, suggests that environmental factors, and not genetics, may explain the trend, the researchers noted. "The diet does affect the autoimmune system in ways that have not been previously recognized," said senior study author Dr. David Hafler, a professor of neurology and immunobiology at ... Read more

Related support groups: Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis, Ankylosing Spondylitis, Rheumatoid Lung

Horizon Pharma Announces FDA Approval of Rayos (prednisone) Delayed-Release Tablets for Rheumatoid Arthritis and Multiple Additional Indications

Posted 31 Jul 2012 by Drugs.com

DEERFIELD, Ill., July 26, 2012 /PRNewswire/ – Horizon Pharma, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Rayos (prednisone) delayed-release tablets (1 mg, 2 mg and 5 mg) to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD). The FDA approval was supported by data bridging the pharmacokinetics of Rayos to immediate-release prednisone and data from the Circadian Administration of Prednisone in RA (CAPRA-1 and 2) trials. The CAPRA-2 trial demonstrated that people with moderate to severe RA treated with Rayos experienced a statistically significant improvement in ACR20 response criteria compared to placebo. The CAPRA-1 trial supported the overall safety of Rayos. "We are extremely pleased the ... Read more

Related support groups: Rheumatoid Arthritis, Prednisone, Asthma, Psoriatic Arthritis, Ankylosing Spondylitis, Polymyalgia Rheumatica, COPD

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