ISTH 2017, Berlin: Octapharma presents exciting Nuwiq® data in previously untreated patients and demonstrates real-life value of personalised prophylaxis for Haemophilia A
Octapharma is playing a prominent role this week at the International Society on Thrombosis and Haemostasis (ISTH) Congress in Berlin, Germany. As a platinum sponsor of the congress, Octapharma’s active involvement includes two sponsored scientific symposia, one of which is dedicated to exploring recent data and real-world experiences with Nuwiq®, the most recent addition to the company’s expanding haematology portfolio. The well-attended symposium, “Towards Life Without Limitation, Growing Experience with Nuwiq ® in Patients with Haemophilia A”, was held on Sunday 9th July and presented key data from clinical trials alongside real-life case studies and experiences with Nuwiq® in the treatment of haemophilia A.
Nuwiq® is a naturally long-acting, 4th generation recombinant factor VIII protein produced in a human cell line. The absence of non-human epitopes makes Nuwiq® an exciting prospect for reducing rates of inhibitor development, a major complication of haemophilia A treatment. The safety and efficacy of Nuwiq® has already been demonstrated in seven clinical trials. This most recent data, presented during the ISTH symposium, focused on using Nuwiq® to treat previously untreated patients (PUPs) as well as on a pharmacokinetic (PK)-based personalised approach to optimising dosage during haemophilia treatment (NuPreviq).
The session, chaired by Pier M. Mannucci, began with a presentation of interim data from NuProtect, a clinical study using Nuwiq® in a cohort of true PUPs, who are at the greatest risk of inhibitor development (manuscript accepted by Haemophilia on July 5th). Ellis J. Neufeld’s presentation, “Focus on PUPs; latest Nuwiq ® efficacy, safety and immunogenicity data in the NuProtect study” described promising inhibitor rate during Nuwiq® treatment based on an interim analysis, particularly for high-titre (HT) inhibitors (12.8% HT; 20.8% overall inhibitors). Convincing evidence of the efficacy of Nuwiq® in bleeding prevention (median annual bleeding rate of zero for spontaneous bleeds; 2.4 for all bleeds) and control of breakthrough bleeds (1 or 2 infusions sufficient to control bleeds in 92.4% of cases) was also presented in this population of PUPs with severe haemophilia A.
Natascha Marquardt went on to discuss her experiences using Nuwiq® to treat a broad range of patients in a single centre in Germany in her talk, “Nuwiq ® in practice: experience from a German treatment centre, the Universitätsklinikum Bonn”. She described excellent efficacy with Nuwiq® in all patient categories (including PUPs, previously treated patients (PTPs) and female carriers) and for all forms of treatment (prophylaxis, on-demand treatment and surgical prophylaxis).
The second half of the session discussed the impressive results from real-life clinical experience with the NuPreviq approach, which uses a PK-based personalised prophylaxis to reduce infusion frequency whilst maintaining a low bleeding rate for haemophilia A patients on an individual patient by patient basis. By providing both a high level of bleed protection and the flexibility for adjustments to precisely meet each person’s unique needs, the NuPreviq Approach helps to optimise FVIII dose quantity and frequency by combining individual PK profiling with robust scientific analysis. John Pasi presented data from his experience with NuPreviq in “The NuPreviq Approach: Optimising PK-guided Personalised Prophylaxis with Nuwiq ® ”, which described the efficacy & safety of personalised PK-based prophylaxis with Nuwiq® in adult PTPs with severe haemophilia A. He described how NuPreviq offers an effective approach to individualising therapy, presenting data that demonstrated excellent protection from bleeds (83% of people were spontaneous bleed-free throughout the 6 month study period) and an overall dose reduction of 7.2%, with 57% of people able to decrease infusions to twice-weekly or less. These convincing results were further supported by the next presentation, “Nuwiq ® in action: an Italian multicentre experience using the NuPreviq approach in practice”, presented by Massimo Morfini. Dr. Morfini described data from an Italian multicentre experience using NuPreviq, again demonstrating excellent bleeding protection and less frequent and/ or reduced overall dosage compared to previous treatment. These exciting data support the fundamental principles of the NuPreviq Approach: that every haemophilia A patient is different, with individual treatment needs and a unique PK profile, which can only be fully addressed with personalised prophylaxis. Such an approach can reduce both the burden of haemophilia treatment on the patient, and the demands placed on hospital resources.
Combined with four poster presentations focusing on Nuwiq® in the scientific sessions, the overwhelmingly positive data presented at ISTH this week promise an exciting and significant future role for Nuwiq® in haemophilia A treatment. Larisa Belyanskaya, Head of IBU Haematology at Octapharma, expressed her enthusiasm regarding the successful symposium, “We at Octapharma are delighted with the very promising results and experiences with Nuwiq ® to date and are excited to share them with the wider haematology community at ISTH. We look forward to the completion of the PUP study and to seeing the full potential of Nuwiq ® and the NuPreviq approach in helping our patients go further in life”.
Olaf Walter, Board Member at Octapharma, commented that “Octapharma is committed to broadening knowledge in haemophilia A and pushing treatment boundaries. International congresses offer a vital platform to facilitate information exchange and Octapharma is very proud to be able to share these positive results at the ISTH 2017 Congress.”
About Haemophilia A
Haemophilia A is an X-linked hereditary disorder caused by FVIII deficiency which, if left untreated, leads to haemorrhages in muscles and joints and consequently to arthropathy and severe morbidity. FVIII replacement prophylactic treatment reduces the number of bleeding episodes and the risk of permanent joint damage. This disorder affects one in every 5,000 to 10,000 men worldwide. Globally, 75% of haemophilia cases are left undiagnosed or untreated. The development of neutralizing FVIII antibodies (FVIII inhibitors) against infused FVIII represents the most serious treatment complication. The cumulative risk of FVIII inhibitor development is reported to be currently up to 39%.
About Nuwiq ®
Nuwiq® is a naturally long-acting, 4th generation rFVIII protein, produced in a human cell line without chemical modification or fusion with any other protein. Nuwiq® is cultured without additives of human or animal origin, is devoid of antigenic non-human protein epitopes and has a high affinity for the von Willebrand coagulation factor. Nuwiq® treatment has been assessed in seven completed clinical trials which included 201 PTPs (190 individuals) with severe HA, including 59 children. Nuwiq® is approved for use in the treatment and prophylaxis of bleeding across all age groups of PTPs with haemophilia A in the EU, US, Canada, Australia, Latin America and Russia. Further worldwide submissions for Nuwiq® are planned.
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.
In 2016, the Group achieved €1.6 billion in revenue, an operating income of €383 million and invested €249 million to ensure future prosperity. Octapharma employs more than 7,100 people worldwide to support the treatment of patients in 113 countries with products across three therapeutic areas:
· Haematology (coagulation disorders)
· Immunotherapy (immune disorders)
· Critical care
Octapharma owns six state-of-the-art production facilities in Austria, France, Germany, Mexico and Sweden.
For more information visit www.octapharma.com
Om Business Wire
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
The Indian Detective, Starring Russell Peters, Premieres Tuesday, December 19, 2017 on Netflix Worldwide20.11.2017 16:00 | Pressemelding
Full release here. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171120005203/en/ (Photo: Business Wire) Following today’s announcement by Netflix, THE INDIAN DETECTIVE , a four-part comedy-drama series starring international comedy sensation Russell Peters, award-winning actor Anupam Kher (The Big Sick, Silver Linings Playbook), the iconic William Shatner (Star Trek), Christina Cole (Suits, Casino Royale), Hamza Haq (mother!, Bon Cop, Bad Cop 2), Akshay Kumar (Star Wars Ep VIII), Meren Reddy (Madiba, Homeland) and Mishqah Parthiephal (Keeping Up with the Kandasamys, Snake Park), will premiere on December 19, 2017 on Netflix worldwide, following an initial run on CTV Canada in November.
Andersen Global Expands Presence in Italy with New Location in Venice-Mestre, on the Venetian Mainland20.11.2017 14:30 | Pressemelding
Andersen Global is proud to announce a new presence in Venice-Mestre, on the Venetian mainland in Italy through the expansion of Italian member firm, Andersen Tax & Legal. In addition, the Milan office will relocate at the end of November. The new office in Mestre and new location in Milan have been established to better serve the growing client base in Italy. Andersen Tax & Legal now has six locations in Italy: Milan, Brescia, Rome, Venice, Mestre, and Monza. Andrea De Vecchi, Office Managing Partner of Andersen Tax & Legal in Italy, and Regional Managing Partner in Europe shared, “Our new location in Venice-Mestre and expanded presence in Milan allow us to better serve our clients and continue to build our capabilities within the region. Through this expansion, we are able to reach new markets and also improve the quality of life for our employees.” Venice-Mestre is a sign
NexPlayer HTML5 Player Fully Compatible with Conviva across All Browsers and Devices20.11.2017 14:00 | Pressemelding
NexStreaming, the provider of NexPlayer SDK, the market leader player SDK for OTT apps, announced today that the NexPlayer HTML5 player is fully compatible with Conviva Video AI Platform. This pre-integrated solution brings great value to video services: from now on, they will be able to enable the highest quality HLS & DASH live streaming across all browsers and devices with NexPlayer, and ensure an outstanding user experience with accurate analytics about the quality of the video experience thanks to Conviva. In this technology integration, NexPlayer HTML5 is fully optimized with Conviva’s QoE analytics. NexPlayer sends information regarding the use of the HTML5 based OTT service, including when the user pauses the video or the video is buffering as well as information about the frame-rate. Conviva measures and analyzes this information so that video service providers and publishers
AGCO’s Innovation Rewarded with Prestigious Awards at Agritechnica 201720.11.2017 14:00 | Pressemelding
AGCO, Your Agriculture Company, (NYSE:AGCO), a worldwide manufacturer and distributor of agricultural equipment and solutions, achieved remarkable success with 17 major awards at the prestigious Agritechnica 2017 event in Hannover, Germany. As a result of the votes cast by an independent expert committee, AGCO was once again one of the most successful manufacturers at Agritechnica 2017 by way of the number of innovation awards received. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171120005614/en/ The new Fendt Track Tractor 943 Vario MT won the treasured award "Machine of the Year 2018" in the Category XXL Tractors (Photo: Business Wire) “Winning these significant awards is a testament to our continued commitment to deliver high-tech solutions for farmers feeding the world,” said Martin Richenhagen
Leading Broker ActivTrades Wins Le Fonti Forex Broker of the Year Award for the Second Time20.11.2017 13:30 | Pressemelding
ActivTrades, one of the world’s leading online Forex Brokers, has won the Le Fonti Forex Broker of the Year Award for the second year running. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171120005576/en/ ActivTrades was awarded at the Le Fonti Awards (Photo: Business Wire) A UK-regulated firm with offices in Europe and the Middle East, ActivTrades was selected as the winner by the editorial staff of over 120 journalists at Le Fonti, the international and independent media company and research centre. Le Fonti credited the broker for “aiming to maximise its clients’ trading through a unique mix of superior value proposition, diverse product offering and stellar customer service”. Le Fonti’s judges added that ActivTrades offers “some of the tightest spreads in the industry” a
European Commission Extends License for Janssen’s ZYTIGA® Plus Prednisone / Prednisolone to Include Earlier Stage Prostate Cancer Patients20.11.2017 13:30 | Pressemelding
Janssen-Cilag International NV (Janssen) today announced that the European Commission (EC) has granted approval to broaden the existing marketing authorisation for ZYTIGA® (abiraterone acetate) plus prednisone / prednisolone to include an earlier stage of metastatic prostate cancer than its current indications. Abiraterone acetate plus prednisone / prednisolone can now be used for the treatment of newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).1 “Prostate cancer is the most common form of cancer in men throughout Europe and today’s decision helps to fill a critical medical need for these patients. We hope to significantly improve the lives of many men across Europe living with this disease and the approval of this treatment in an earlier stage of prostate cancer helps address this,”
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom