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Eculizumab News

FDA Approves Soliris (eculizumab) for the Treatment of Patients with Generalized Myasthenia Gravis (GMG)

Posted 26 Oct 2017 by Drugs.com

NEW HAVEN, Conn.--(BUSINESS WIRE) October 23, 2017 --Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced today that the U.S. Food and Drug Administration (FDA) has approved Soliris (eculizumab) as a treatment for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody-positive. In the Phase 3 REGAIN study and its ongoing open-label extension study, Soliris demonstrated treatment benefits for patients with anti-AchR antibody-positive gMG who had previously failed immunosuppressive treatment and continued to suffer from significant unresolved disease symptoms, which can include difficulties seeing, walking, talking, swallowing and breathing. These patients are at an increased risk of disease exacerbations and crises that may require hospitalization and intensive care and may be life-threatening. These patients represent approximately ... Read more

Related support groups: Myasthenia Gravis, Soliris, Eculizumab

Cancer Drugs' High Prices Not Justified by Cost of Development, Study Contends

Posted 12 Sep 2017 by Drugs.com

TUESDAY, Sept. 12, 2017 – Excusing the sky-high price tags of many new cancer treatments, pharmaceutical companies often blame high research and development (R&D) costs. But a new analysis, focused on 10 new cancer drugs, finds those costs may have been greatly exaggerated – and the return on investment for drug companies is lucrative indeed. The study found that the typical R&D process for a new cancer medication spans about seven years, with an average per-drug cost of between $648 million and $794 million. Pricey, yes – but still far below the $2.7 billion-per-drug R&D figure determined by a 2016 Tufts University investigation. It's that number that drug companies have pointed to as their average R&D cost per drug. And the pay-off, once a new cancer drug reaches the market, can be enormous, the new study found. According to the researchers, after an average of about four years on ... Read more

Related support groups: Cancer, Imbruvica, Xtandi, Ibrutinib, Ruxolitinib, Jakafi, Soliris, Iclusig, Folotyn, Adcetris, Cabometyx, Cometriq, Cabozantinib, Brentuximab, Vincristine Liposomal, Eculizumab, Onivyde, Ponatinib, Enzalutamide, Irinotecan Liposomal

Kidney Woes Tied to Raised Cancer Risk, Study Finds

Posted 12 Nov 2015 by Drugs.com

THURSDAY, Nov. 12, 2015 – Kidney failure and having a kidney transplant may increase the risk for certain types of cancer, a new study suggests. Poor kidney function and immune system-suppressing drugs may be behind this increased risk, according to Elizabeth Yanik, of the U.S. National Cancer Institute, and colleagues. For the study, published in the Nov. 12 online edition of the Journal of the American Society of Nephrology, the researchers looked at data from more than 200,000 U.S. kidney transplant candidates and recipients. Along with finding that these patients are at increased risk for certain types of cancer, the investigators also identified clear patterns of risk associated with different types of treatment. However, the associations seen in the study do not prove cause-and-effect. The risk of kidney and thyroid cancers was especially high when kidney failure patients were on ... Read more

Related support groups: Cancer, Methotrexate, Renal Failure, Gilenya, Tysabri, CellCept, Imuran, Xolair, Chronic Kidney Disease, Orencia, Revlimid, Arava, Leflunomide, Tecfidera, Azathioprine, Afinitor, Peritoneal dialysis, Mycophenolate Mofetil, Entyvio, Aubagio

FDA Medwatch Alert: Soliris (Eculizumab) Concentrated Solution for Intravenous Infusion by Alexion: Recall - Visible Particles

Posted 16 Dec 2013 by Drugs.com

ISSUE: Alexion Pharmaceuticals, Inc. is providing information regarding a previously communicated voluntary recall of two lots of Soliris (eculizumab) Concentrated Solution for Intravenous Infusion. As stated on Nov. 12, 2013, the two lots were found to contain visible particles. At that time, Alexion provided instructions to return any unused vials of Soliris from these two lots at the distributor level. Alexion is now providing the same instructions at the hospital/user level. The administration of particulate, if present in a parenteral drug, poses a potential safety risk to patients in two general areas: immunogenicity and thromboembolic events. Particulates could cause blockage of flow of blood in vessels, which could be life-threatening. To date, there have been no product complaints of particulates, or identifiable safety concerns attributed to the product consumed from the ... Read more

Related support groups: Soliris, Paroxysmal Nocturnal Hemoglobinuria, Eculizumab

Soliris (eculizumab) Approved by FDA for All Patients with Atypical Hemolytic Uremic Syndrome (aHUS)

Posted 25 Sep 2011 by Drugs.com

CHESHIRE, Conn.--(BUSINESS WIRE)--Sep 23, 2011 - Alexion Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Soliris® (eculizumab) for the treatment of all pediatric and adult patients with atypical hemolytic uremic syndrome (aHUS). aHUS is an ultra-rare, life-threatening, genetic disease that progressively damages vital organs, leading to stroke, heart attack, kidney failure and death.1 The morbidity and premature mortality in aHUS is caused by chronic uncontrolled activation of the complement system, resulting in the formation of blood clots in small blood vessels throughout the body, known as thrombotic microangiopathy or TMA.2,3 Despite current supportive care, more than half of all patients with aHUS die, require kidney dialysis or have permanent kidney damage within 1 year of diagnosis.4 Soliris, a first-in-class terminal complement ... Read more

Related support groups: Soliris, Eculizumab, Hemolytic Uremic Syndrome

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Related Condition Support Groups

Hemolytic Uremic Syndrome, Myasthenia Gravis, Paroxysmal Nocturnal Hemoglobinuria

Related Drug Support Groups

Soliris

Eculizumab Patient Information at Drugs.com