Ablynx submits a marketing authorisation application to the european medicines agency for caplacizumab, its anti-vwf nanobody, for the treatment of attp _ nachricht _ finanzen. net


The MAA includes data from the Phase II TITAN study in patients with aTTP which demonstrated a statistically significant and clinically meaningful benefit of caplacizumab treatment in reducing the time to platelet count normalisation and reducing recurrences while on drug treatment. Can to usd Results of post-hoc analyses of the Phase II TITAN study further demonstrated that caplacizumab dramatically reduced the number of patients experiencing major thromboembolic events, as compared to placebo.

“As pioneers in the treatment of aTTP, we are committed to making caplacizumab available to patients suffering from this severe disease for which there is currently no specifically approved drug available.

Usd brl This is a very important moment in the development of Ablynx, as we prepare to commercialise our first product and become a fully vertically integrated biopharmaceutical company. Exchange rate usd myr We look forward to working with the EMA during this review process.”

Caplacizumab is a highly potent and selective bivalent anti-vWF Nanobody that received Orphan Drug Designation in Europe and the United States in 2009. The future of digital marketing is you Caplacizumab blocks the interaction of ultra-large vWF multimers (ULvWF) with platelets and, therefore, has an immediate effect on platelet aggregation and the ensuing formation and accumulation of the microclots that cause the severe thrombocytopenia, tissue ischemia and organ dysfunction in aTTP. Historical exchange rates usd to inr This immediate effect of caplacizumab protects the patient from the manifestations of the disease while the underlying disease process resolves.

The efficacy and safety of caplacizumab in conjunction with the standard of care of plasma exchange (PEX) and immunosuppression, were evaluated in the Phase II TITAN study in 75 patients with aTTP. E mini msci emerging markets futures Caplacizumab was well-tolerated and the primary endpoint was met (p=0.005), with caplacizumab treatment resulting in a nearly 40% reduction in time to platelet count normalisation as compared to placebo (i.e., a faster reversion of thrombocytopenia with consequent reduced use of PEX [1]). Us stock futures tomorrow Moreover, during treatment, caplacizumab reduced recurrences of aTTP by 71% compared to placebo 1. Euro conversion to usd Post-hoc analyses of the Phase II TITAN study data were performed to assess the impact of caplacizumab on a composite endpoint of major thromboembolic complications and aTTP-related mortality, as well as on refractoriness to standard treatment. Eur usd historical chart The results demonstrate that a clinically meaningful lower proportion of subjects treated with caplacizumab experienced one or more major thromboembolic events, or died, as compared to placebo (11.4% versus 43.2%) 1. Currency converter usd to rm In addition, fewer caplacizumab-treated patients, compared to those who received placebo, were refractory to treatment [2] (5.7% versus 21.6%; and 0% versus 10.8%, respectively depending on the definition of refractoriness [3]). Market futures cnbc There were two deaths in the placebo group and both of those patients were refractory to treatment; no deaths were reported in the caplacizumab group.

The Phase III HERCULES study in patients with aTTP is currently ongoing and is expected to support a BLA filing in the United States. Gender differences in language This randomised, double-blind, placebo-controlled study will evaluate the efficacy and safety of caplacizumab in patients with aTTP when administered in addition to the standard-of-care. Euro chart 2016 The primary endpoint is time to platelet count normalisation, a measure of prevention of further microvascular thrombosis. Translate binary code Key secondary endpoints include a composite endpoint consisting of TTP-related mortality, recurrence of TTP and major thromboembolic events during study drug treatment, as well as the prevention of recurrence of TTP during the study period, refractoriness to treatment, and the effect on biomarkers of organ damage. Chf usd conversion Results from this Phase III study are expected in the second half of 2017.

A three-year follow-up study of patients participating in the HERCULES study is also in progress and will further evaluate the long-term safety and efficacy of caplacizumab and repeated use of caplacizumab, as well as characterizing the long-term impact of aTTP.

aTTP is an ultra-rare, acute, life-threatening, blood clotting disorder. Latest exchange rate pound to euro It has a sudden onset caused by impaired activity of the ADAMTS13 enzyme, leaving ULvWF molecules uncleaved (vWF is an important protein involved in the blood clotting process). Gender identity test These ULvWF molecules spontaneously bind to blood platelets, resulting in severe thrombocytopenia (very low platelet count) and micro-clot formation in small blood vessels throughout the body [4], leading to thrombotic complications and widespread organ damage [5].

Despite the current standard-of-care treatment of PEX and immunosuppression, episodes of aTTP are still associated with a mortality rate of up to 20%, with most deaths occurring within 30 days of diagnosis [6]. Usd to aed Furthermore, patients are at risk of acute thromboembolic complications (e.g. Usd to zwd stroke, venous thrombosis and myocardial infarction) and of recurrence of disease. Pounds to usd calculator The recurrence rate has been reported to range from 10-84% [7] and recurrences typically occur within 1-2 years [8] but have been reported up to 30 years after the initial episode [9]. Solving problems In addition, some patients are refractory to therapy 3, which is associated with a very poor prognosis for survival of an acute episode of aTTP. Fraction operations worksheet Long term, patients are at increased risk of hypertension, major depression, and premature death [10].

Ablynx is a biopharmaceutical company engaged in the development of Nanobodies, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Verizon troubleshooting Ablynx is dedicated to creating new medicines which will make a real difference to society. Famous quotes about life changes Today, the Company has more than 45 proprietary and partnered programmes in development in various therapeutic areas including inflammation, haematology, immuno-oncology, oncology and respiratory disease. Usd chf chart The Company has collaborations with multiple pharmaceutical companies including AbbVie, Boehringer Ingelheim, Eddingpharm, Merck & Co., Inc., Merck KGaA, Novartis, Novo Nordisk and Taisho Pharmaceuticals. Usd to aed rate The Company is headquartered in Ghent, Belgium. Futures and commodity market news More information can be found on www.ablynx.com.

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