견적문의

LACHEN, SWITZERLAND--( / )--Octapharma announced today that the human fibrinogen concentrate fibryga® has received approval for use in treatment of acquired fibrinogen deficiency (AFD) in 15 European countries. The approval extends the market authorisation for fibryga®, which is already approved for use in patients with congenital fibrinogen deficiency. The addition represents a major milestone for bleeding management in critical care settings.

Fibrinogen is a coagulation factor essential for blood clotting, and therefore to stop excessive bleeding. Unlike with rare congenital fibrinogen deficiencies, AFD arises when excessive blood loss, and so clotting, caused by trauma or major surgery use up the fibrinogen reserves in the blood. Fibrinogen replacement is a recommended first line therapy in the management of patients developing complications from uncontrolled bleeding.

Fibryga® is a highly purified, dual pathogen-inactivated, lyophilised human fibrinogen concentrate for intravenous infusion, with a rapid, convenient reconstitution device for effective correction of fibrinogen deficiency.

The approval of fibryga® for use in AFD is based on results of the FORMA-05 clinical study. This phase II, prospective, randomised, single-blind, controlled, non-inferiority study compared the efficacy of fibryga® with that of standard of care (cryoprecipitate) during cytoreductive surgery to treat the rare cancer Pseudomyxoma peritonei. This major and complex surgical procedure is associated with extensive blood loss and patients are at high risk of developing AFD.

The haemostatic efficacy was achieved by 100% for fibryga® and for cryoprecipitate. Levels of the fibrin-stabilising factor XIII were maintained in both treatment groups. However, patients treated with fibryga® experienced more rapid and pronounced replenishment of plasma fibrinogen levels and blood clot firmness. No thromboembolic events were reported in patients treated with fibryga® (n = 22) compared with seven in those treated with cryoprecipitate (n = 23).

Importantly, fibryga® was administered an average of 24 minutes earlier than cryoprecipitate, reflecting its rapid reconstitution and ease of use. This is especially important for situations where time to treatment is critical for patient outcomes.

Olaf Walter, Board Member at Octapharma, commented that “Fibrinogen replacement is an important strategy for management of bleeding, particularly in the surgical setting. The label extension represents an important step in the product’s development. We at Octapharma are proud to be contributing to rapid and effective bleeding control in this critical clinical setting as part of our goal of improving the lives of patients”.

Sigurd Knaub, Senior Vice President of Clinical R&D at Octapharma, added: “The FORMA-05 trial represents the first analysis of fibryga® in a controlled clinical study of AFD, and provides conclusive evidence for regulatory approval of a label extension.”

If you want to learn more about AFD and fibryga® please visit:

The FORMA-05 trial results are available here ().

Roy A et al. J Thromb Haemost 2019. Publication accepted and in process.

About fibryga®

fibryga® is a novel fibrinogen concentrate produced from pooled plasma providing fast reconstitution, dual pathogen safety, high level of purity, and functionality for the treatment of patients where fast and efficacious replacement of fibrinogen is needed. Indication of use may differ by country. Please consult local product information for country specific information or contact an Octapharma representative.

About Octapharma

The vision of Octapharma is: “Our passion drives us to provide new health solutions advancing human life”. Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. As a family-owned company, Octapharma believes in investing to make a difference in people’s lives and has been doing so since 1983; because it’s in our blood. Our company values are Ownership, Integrity, Leadership, Sustainability and Entrepreneurship.

In 2018, the Group achieved €1.8 billion in revenue, an operating income of €346 million and invested €240 million into R&D and in capital expenditures in order to ensure future prosperity. Octapharma employs 8,314 people worldwide to support the treatment of patients in 115 countries with products across three therapeutic areas:

· Haematology (coagulation disorders)

· Immunotherapy (immune disorders)

· Critical care (bleeding management and functional volume replacement)

Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden.

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LAUSANNE, SWITZERLAND--( / )--Galderma, Nestle Skin Health’s medical solutions business, presented the final results from a Phase 오오애니애니추천 LAUSANNE,dose-ranging study 부천종합운동장역홀덤바 미팅포유 of nemolizumab, an investigational therapy in adult patients with moderate-to-severe atopic dermatitis (AD), at the late-breaking session of the 부천종합운동장역홀덤바 여캠 2019 번카지노바 여캠방 American Academy of Dermatology annual meeting (March 부천종합운동장역홀덤바 야동영상 1-5).

Nemolizumab is a first-in-class investigational monoclonal antibody that blocks signaling of 부천종합운동장역홀덤바 성교 IL-31, a cytokine that plays a key role in the pathogenesis of moderate-to-severe AD. 번카지노바 페티쉬코리아

Moderate to severe AD 부천종합운동장역홀덤바 엉덩이짱 is a serious, chronic form of 번카지노바 야한그림 eczema associated with 번카지노바 애무 a high burden of disease linked to itch, sleep deprivation and significant quality of life impairment. This double blind, placebo-controlled, 24 week, dose-ranging Phase 2b study enrolled 226 subjects with moderate-to-severe AD not adequately controlled with topical 번카지노바 섹스걸 corticosteroids. All groups received concomitant topical corticotherapy.

This study met the primary endpoint of a greater improvement in Eczema Area and Severity 부천종합운동장역홀덤바 패티시 Index (EASI) scores from 번카지노바 baseline compared with placebo. A 73 percent reduction in mean EASI score was observed 번카지노바 파워볼사이트추천 at Week 24 with nemolizumab compared with 58 percent for placebo.

Nemolizumab was well-tolerated across all dose levels in 번카지노바 this trial. The most common adverse events observed were nasopharyngitis and 부천종합운동장역홀덤바 upper respiratory tract infection. Subjects with pre-existing asthma reported 번카지노바 파워볼엔트리 an increase in asthma related events; these events were mostly mild and were reversible under treatment.

Nemolizumab-treated subjects 번카지노바 showed statistically significant improvements in key secondary efficacy measures compared 번카지노바 동행복권이란 with placebo after 16 번카지노바 파워볼엔트리픽 weeks of 부천종합운동장역홀덤바 treatment:

-33 모모벳 -33of nemolizumab-treated subjects achieved clear or almost-clear skin as measured by an investigator’s 부천종합운동장역홀덤바 엔트리파워볼패턴 global 부천종합운동장역홀덤바 엔트리파워볼분포도 assessment (IGA) score of 0 or 1, compared with 12 percent of 부천종합운동장역홀덤바 키노사다리조작 placebo-treated subjects 번카지노바 야사진 (p=0.008);

-49 번카지노바 아들벌 -49of nemolizumab-treated subjects achieved 부천종합운동장역홀덤바 나눔로또키노사다리 75 percent reduction 부천종합운동장역홀덤바 키노사다리작업 in EASI 번카지노바 score compared with 19 번카지노바 percent of placebo-treated subjects (p<0.01); and

-68 percent of nemolizumab-treated subjects achieved at 번카지노바 섹스하는법 부천종합운동장역홀덤바 섹스하는법 least 4-point reduction in itch, as measured by 부천종합운동장역홀덤바 로또번호추출기 the pruritus numerical-rating scale (NRS) score, compared with 21 토렌트와 -68reduction in placebo-treated subjects. (p<0.001).

In addition, nemolizumab was associated with 번카지노바 a rapid onset of action 번카지노바 야동애니 on AD symptoms: nemolizumab-treated subjects showed early 토토프로토매니아 Insignificant improvements in 부천종합운동장역홀덤바 itching 부천종합운동장역홀덤바 로토리치 and sleep compared with placebo-treated subjects as measured by pruritus NRS and sleep disturbance NRS. 부천종합운동장역홀덤바 로또당

“We are excited by this Phase 2b late-breaking presentation and to 부천종합운동장역홀덤바 슈어툰 be able to report that nemolizumab met all study endpoints in treatment of moderate 부천종합운동장역홀덤바 토렌트집 to severe atopic dermatitis. These 번카지노바 new data have added to growing evidence generated 부천종합운동장역홀덤바 야나무 with our partner, Chugai, highlighting the importance of the IL-31 pathway as a key driver in moderate to severe atopic dermatitis,” said Thibaud Portal, Ph. D., Global Vice President of Galderma’s Prescription Business.

“The results of this Phase 2b study showed that nemolizumab significantly improved atopic dermatitis signs and very rapidly improved atopic dermatitis symptoms, including pruritus and sleep disturbance. These findings show why nemolizumab is such a promising new investigational drug 번카지노바 로또당첨번호통계 아오이소라 “Thehow it could be helpful in treating moderate to severe atopic dermatitis,” 부천종합운동장역홀덤바 로또정보업체 said Dr. Jonathan I Silverberg, Principal Investigator of the Phase 2b program, from the Department of Dermatology, North Western University, Chicago, IL, USA.

Galderma is now actively 번카지노바 preparing 부천종합운동장역홀덤바 싸밤 for a 수색동방석집 Galderma번카지노바 무료로또번호생성기 Phase 번카지노바 3 pivotal program which will be implemented by mid-2019. 부천종합운동장역홀덤바 로또1등당첨되기

About 번카지노바 오피러브 부천종합운동장역홀덤바 오피러브 the 방자전주소찾기 AboutPathway and 부천종합운동장역홀덤바 Atopic Dermatitis

Moderate-to-severe atopic dermatitis (AD), a serious, chronic form of eczema, is a systemic inflammatory disease characterized by an allergic response driven by a subset of immune cells called Type 2 helper T cells, 부천종합운동장역홀덤바 오빠방콕 or Th2 cells. IL-31, a cytokine released by Th2 cells, is involved in AD associated pruritus 부천종합운동장역홀덤바 로또당첨번호확률 by interacting with IL-31 receptor alpha expressed by neuron. IL-31 is also thought to play a role in AD skin inflammation and AD 번카지노바 서울비아 skin barrier impairment. Moderate-to-severe 번카지노바 로또맞추는방법 forms of AD can be characterized by pronounced cutaneous dryness, and skin lesions marked by redness, infiltration/papulation, crusting/oozing, and lichenification, with periods of lesion exacerbation accompanied by intense itching, scratching, and skin damage that can lead 부천종합운동장역홀덤바 로또가장많이나오는숫자 to secondary infections. Moderate-to-severe AD can negatively impact patients’ lives and is associated with a high burden to patients particularly with itching, sleep deprivation and depression.

About 번카지노바 로또회차별당첨금 부천종합운동장역홀덤바 로또회차별당첨금 어은동성인용품 About번카지노바 퓨처비전 부천종합운동장역홀덤바 퓨처비전

Nemolizumab, a first-in-class humanized 번카지노바 monoclonal antibody, is directed against the IL-31R alpha, which blocks 부천종합운동장역홀덤바 로또1등되는법 signaling from both IL-31. Nemolizumab, initially developed by Chugai, was subsequently licensed 부천종합운동장역홀덤바 이번주로또 야구리망가 Nemolizumab,Nestle Skin Health in 부천종합운동장역홀덤바 포시즌TV 2016. Nemolizumab is an investigational agent under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority. 번카지노바 패스TV

About 번카지노바 Galderma 부천종합운동장역홀덤바 로또운세

Galderma, Nestle Skin Health’s medical solutions business, was created in 1981 부천종합운동장역홀덤바 스포츠관련 and is now present in over 100 번카지노바 7MSPORT countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in 만화방 Galderma,and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit

View source version on businesswire.com:Korea Newswire distributes your news across every 번카지노바 로또보너스번호 media 부천종합운동장역홀덤바 channels through the industry’s largest press 부천종합운동장역홀덤바 카지노부대 release distribution 부천종합운동장역홀덤바 network 번카지노바 나의로또번호