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RdNB-~gWvQ@VP[VIIINMQutˆ}vGN{|1  IgG1vFcMOT _ S)R(uNy)Y6qX[(Wv ^oir(WSOQve0=\{FcTb/g]O(uǏ15t^ FO~veP/f*N\vQ^(uN@SuluvlQS0 12 GSK announces start of phase III study of sirukumab in Giant Cell Arteritis GSK today announced that dosing has commenced in a phase III study evaluating sirukumab, a human anti-interleukin (IL)-6 monoclonal antibody, for the treatment of patients with giant cell arteritis (GCA). GCA, a disease characterised by inflammation of large and medium sized arteries predominantly in the head and neck, occurs in people aged 50 years or over. Patients typically experience severe headache, visual loss, jaw and muscular pain and may be at risk of permanent sight loss if not treated promptly. The mainstay of treatment is with high doses of steroids to rapidly reduce the inflammation and prevent sight loss. In order to minimise side effects that can occur with high doses and long term use, steroids are tapered after remission to lower maintenance doses. However, disease relapse is common during steroid taper and remission with steroids is often followed by subsequent relapse requiring repeat high dose treatment. As a result over 70% of patients experience significant side effects from steroids such as osteoporosis, cataract, hypertension and type 2 diabetes mellitus. The phase III randomised, double-blind, placebo-controlled study (named the  SIRRESTA study) will evaluate the efficacy and safety of two subcutaneous doses of sirukumab (100mg every two weeks and 50mg every four weeks) with a pre-specified tapering dose of prednisone for the treatment of GCA. This approach will specifically answer whether treatment with sirukumab can reduce the duration of steroid treatment typical in clinical practice. The study comprises two distinct parts: a 52 week double-blind treatment phase (Part A) and a 104 week long term extension phase (Part B). The primary endpoint of the study is the proportion of patients that achieve sustained remission. Paul-Peter Tak, Senior Vice President, GSK Immuno-Inflammation R&D, said:  The use of high dose steroids to treat giant cell arteritis can cause severe side effects with prolonged use. Alternative treatments are required and we believe sirukumab could be an important option for patients with this disease. The start of our study with sirukumab for GCA, which is currently under investigation for rheumatoid arthritis, marks the progress we are making to apply our knowledge of the underlying cause of a variety of immune-mediated inflammatory diseases and explore the potential of our immuno-inflammation pipeline to treat multiple conditions. Sirukumab is not approved as a treatment for any indication anywhere in the world. 13 Praxbind (idarucizumab) approved in European Union for the specific reversal of Pradaxa (dabigatran etexilate) The European Commission has approved Praxbind (idarucizumab), a treatment to rapidly and specifically reverse the anticoagulant effects of Pradaxa (dabigatran etexilate) in cases of emergency surgery /urgent procedures or in situations of life-threatening or uncontrolled bleeding.1Idarucizumab is the first specific reversal agent for a non-vitamin K antagonist oral anticoagulant (NOAC) to be approved in the European union.1  Anticoagulants offer important benefits to patients at risk of thromboembolic events. However, even though rare, there will be situations when reversal of anticoagulation is medically necessary, said Professor Harald Darius, lead investigator for the RE-VERSE AD"! clinical study in Germany, and Director of the Department of Cardiology, Vascular Medicine, Nephrology and Intensive Care Medicine, Vivantes Neukoelln Medical Centre, Berlin.  The approval of Praxbind now provides me and my colleagues with an important option to manage patients taking Pradaxa in situations when speed of reversal matters.  I am delighted that we are now able to offer Praxbind, the only specific reversal agent for a NOAC, to patients and physicians in Europe, commented Professor Jrg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim.  With this approval, Boehringer Ingelheim is again leading the evolution of anticoagulation care, as we did with the introduction of Pradaxa. And while we anticipate that Praxbind will be rarely used in clinical practice, the availability of this specific reversal agent can now give physicians and patients added confidence in choosing Pradaxa. The approval of idarucizumab by the European Commission follows the positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency in September 2015.5Idarucizumab was already approved by the U.S. Food and Drug Administration in October 2015.6 The approval is based on data from healthy volunteers, as well as results from an interim analysis of the RE-VERSE AD"! clinical study.2-4,7In the studies, the reversal effects of idarucizumab were evident immediately, within minutes after administration of 5 grams of idarucizumab.2-4Reversal was complete and sustained for a minimum of 12 hours in almost all patients.2-4In the data submitted for approval, including 123 patients from REVERSE-AD"! and more than 200 volunteers previously given idarucizumab no safety concerns or prothrombotic signals were observed.2-4,7,8 Boehringer Ingelheim is committed to making idarucizumab available as widely as possible and will launch idarucizumab in the European Union countries as soon as national requirements allow. 14 Roche receives EU approval of Cotellic for use in combination with Zelboraf in advanced melanoma Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved CotellicTM (cobimetinib) for use in combination with Zelboraf (vemurafenib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. The EU approval is based on data that showed Cotellic plus Zelboraf helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live for more than a year without their disease worsening1.  There has been significant progress in the treatment of melanoma, with more medicines being approved in the past five years than in the previous 30, said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. "Together, Cotellic plus Zelboraf more strongly suppressed cancer growth than Zelboraf alone. This underscores the critical role of combination medicines in helping melanoma patients live longer without their disease worsening." Today s EU approval is based primarily on results of the Phase III coBRIM study, which showed that people with previously untreated BRAF V600 mutation-positive advanced melanoma who were being treated with the MEK inhibitor Cotellic in combination with Zelboraf lived a median of one year (12.3 months) without their disease worsening or death (progression-free survival; PFS) compared to 7.2 months with Zelboraf alone (hazard ratio [HR]=0.58; 95 percent confidence interval [CI] 0.46-0.72).1 The objective response rate (ORR) with the combination was 70 percent (16 percent complete response [CR], 54 percent partial response [PR]) compared to 50 percent (11 percent CR, 40 percent PR) in the Zelboraf arm.1 The safety profile of Cotellic plus Zelboraf was consistent with safety data previously reported. The most common adverse events in the combination arm were diarrhea, rash, nausea, fever, sun sensitivity, liver lab abnormalities, elevated creatine phosphokinase (CPK, an enzyme released by muscles) and vomiting. Additional data were presented on November 21, 2015 at the Society for Melanoma Research congress demonstrating that the combination of Cotellic plus Zelboraf met its secondary endpoint of improving overall survival compared to Zelboraf alone. These data will be submitted to the European Medicines Agency for consideration and inclusion in the label. Cotellic in combination with Zelboraf is now approved in the EU and Switzerland for the treatment of people with BRAF V600 mutation-positive advanced melanoma. In the US, the combination is approved for the treatment of people with BRAF V600E or V600K mutation-positive advanced melanoma. Further country approvals are anticipated in 2016. 15 Roche's blockbuster-hopeful immunotherapy shows promise in skin cancer Roche ( HYPERLINK "http://www.fiercebiotech.com/tags/roche" $RHHBY), angling for third place among companies in the growing field of HYPERLINK "http://www.fiercebiotech.com/tags/immuno-oncology" immuno-oncology, is touting promising early data for its so-called checkpoint inhibitor in HYPERLINK "http://www.fiercebiotech.com/tags/skin-cancer" skin cancer, building its case for the wide use of its in-development therapy. In a 17-patient Phase Ib study, combining Roche's HYPERLINK "http://www.fiercebiotech.com/tags/atezolizumab" atezolizumabwith the on-the-market HYPERLINK "http://www.fiercebiotech.com/tags/zelboraf" Zelborafshrank tumors for 76% of volunteers, and three patients had their melanoma disappear completely, the company said. Side effects in the study were "manageable and generally reversible," Roche said, with no dose-limiting toxicities or treatment-related deaths. Atezolizumab works by blocking a protein checkpoint called HYPERLINK "http://www.fiercebiotech.com/tags/pd-l1" PD-L1, thereby unblinding the immune system to malignant presences and leading a T cell attack on cancer. Roche, like its rivals in the field, is working through a fleet of clinical trials that mix and match checkpoint inhibitors with other oncology agents, testing their products on a wide array of cancers in hopes of eventually winning broad FDA approvals.       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