Roches Tecentriq®▼ i kombinasjon med nab-paclitaxel og karboplatin forlenger overlevelse hos pasienter med ikke-småcellet lungekreft

Pressemeldinger   •   okt 26, 2018 09:05 CEST

Roches MS-medisin Ocrevus®▼ blir ikke tilgjengelig for bruk i offentlige sykehus i Norge for behandling av attakkvis og tidlig primær progressiv multippel sklerose

Pressemeldinger   •   okt 22, 2018 15:47 CEST

Lovende resultater for målrettet behandling med entrectinib hos pasienter med NTRK-mutasjon positive krefttyper

Pressemeldinger   •   okt 21, 2018 20:35 CEST

Roches Tecentriq®▼ i kombinasjon med Abraxane, som førstelinjebehandling, forbedrer utfallet til pasienter med PD-L1-positiv metastatisk trippel-negativ brystkreft

Pressemeldinger   •   okt 21, 2018 08:45 CEST

Positive fase III-data for Roches Kadcyla® (trastuzumabemtansin) innen tidlig HER2-positiv brystkreft

Pressemeldinger   •   okt 16, 2018 00:02 CEST

Roches molekyl entrectinib: Studier viser vedvarende respons for en undergruppe pasienter med små-cellet lungekreft

Pressemeldinger   •   sep 26, 2018 11:26 CEST

Tecentriq ®▼i kombinasjon med cellegift (kjemoterapi) kan bidra til at noen pasienter med utbredt småcellet lungekreft lever lenger

Pressemeldinger   •   sep 26, 2018 10:34 CEST

Beslutningsforum sier nei til RoActemra® for kjempecellearteritt

Pressemeldinger   •   aug 27, 2018 14:10 CEST

Oslo, 27. august 2018: Beslutningsforum bestemte i dag at det revmatiske legemiddelet RoActemra (tocilizumab) ikke innføres til behandling for kjempecellearteritt. Norske pasienter vil dermed ikke ha tilgang til den første nye behandlingen for denne sykdommen på over 50 år.

Phase III CAPSTONE-2 study showed that baloxavir marboxil reduced symptoms in people at high risk of complications from the flu

Pressemeldinger   •   aug 07, 2018 16:00 CEST

  • Baloxavir marboxil – an investigational oral, single-dose antiviral – is the first flu medicine with a novel proposed mechanism of action in nearly 20 years and to demonstrate significant efficacy in high-risk patients
  • Influenza, or “flu,” represents a serious threat to public health – globally, annual epidemics result in 3 to 5 million cases of severe disease, millions of hospitalizations and up to 650,000 deaths worldwide1, 2, 3, 4, 5

Basel, 17 July 2018 - Roche today announced that the phase III CAPSTONE-2 study assessing the safety and efficacy of baloxavir marboxil in people at high risk of complications from the flu met the study’s primary objective, and showed superior efficacy in the primary endpoint of time to improvement of influenza symptoms versus placebo The Centers for Disease Control and Prevention (CDC) defines people at high risk for serious flu complications to include adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, diabetes, or heart disease – for these people, flu can lead to hospitalization or even death.6 Baloxavir marboxil also demonstrated superior efficacy compared to placebo and oseltamivir for important secondary endpoints, including reducing the time that the virus continued to be released (viral shedding) and reducing viral levels in the body. Furthermore, baloxavir marboxil significantly reduced the incidence of influenza-related complications compared to placebo. Baloxavir marboxil was well tolerated and no safety signals were identified. Full results from the CAPSTONE-2 study will be presented at upcoming medical meetings. Baloxavir marboxil was discovered and developed by Shionogi & Co., Ltd., and is sold in Japan under the trade name Xofluza®.

“Baloxavir marboxil is the first antiviral to show a clinically meaningful benefit in people who are most susceptible to complications from the flu, including older people and those living with certain medical conditions,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We plan to submit the results of this second positive phase III study for baloxavir marboxil to healthcare authorities, and look forward to discussing next steps since there are no current antiviral medicines approved to specifically treat this high-risk population.”

Baloxavir marboxil has already demonstrated a clinically significant benefit over placebo in otherwise healthy people in the phase III CAPSTONE-1 study. The U.S. Food and Drug Administration (FDA) recently accepted a New Drug Application (NDA) and granted Priority Review to baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older based on the CAPSTONE-1 study and the phase II study, and is expected to make a decision on approval by 24 December 2018. If approved, baloxavir marboxil would be the first single-dose oral antiviral, and the first medicine with a novel proposed mechanism of action to treat the flu in nearly 20 years.

About CAPSTONE-2

CAPSTONE-2 is a phase III, multicentre, randomised, double-blind study that evaluated a single dose of baloxavir marboxil compared with placebo and oseltamivir in people 12 years or older who are at a high risk of complications from the flu. The Centers for Disease Control and Prevention (CDC) defines people at high risk for serious flu complications to include adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, diabetes, or heart disease.6 The study was conducted globally by Shionogi & Co., Ltd.

Participants enrolled in the study were randomly assigned to receive a single dose of 40 mg or 80 mg of baloxavir marboxil (according to body weight), placebo or 75 mg of oseltamivir twice a day for 5 days. The primary objective of the study evaluated the efficacy of a single dose of baloxavir marboxil compared with placebo by measuring the time to improvement of influenza symptoms. Important secondary endpoints were time to resolution of fever, time to cessation of viral shedding and the proportion of participants positive for influenza virus titre, or virus levels in the body, by time point, and incidences of influenza-related complications.

About baloxavir marboxil

Baloxavir marboxil is a first-in-class, single-dose investigational oral medicine with a novel proposed mechanism of action designed to target the influenza (“flu”) A and B viruses, including oseltamivir-resistant strains and avian strains (e.g. H7N9, H5N1).7, 8, 9 Unlike other currently available antiviral treatments, baloxavir marboxil is the first in a new class of antivirals designed to inhibit the cap-dependent endonuclease protein within the flu virus, which is essential for viral replication.10, 11

Baloxavir marboxil will also be studied in a phase III development programme including paediatric and severely ill hospitalised patients with influenza.

Baloxavir marboxil was discovered by Shionogi & Co., Ltd. and is being developed globally by the Roche Group (which includes Genentech in the U.S.) and Shionogi & Co., Ltd. Under the terms of this agreement, Roche holds worldwide rights to baloxavir marboxil excluding Japan and Taiwan, which will be retained exclusively by Shionogi & Co., Ltd. Baloxavir marboxil was approved in February 2018 by the Japanese Ministry of Health, Labour and Welfare for the treatment of influenza types A and B in adult and paediatric patients, and is being commercialised in Japan and marketed under the brand name Xofluza®.

About Roche in influenza

Influenza, or flu, is one of the most common, yet serious, infectious diseases. Globally, annual epidemics result in 3 to 5 million cases of severe disease, millions of hospitalizations and up to 650,000 deaths worldwide.1, 2, 3, 4, 5 For patients at a higher risk of flu complications, like pneumonia and bronchitis, the flu can lead to hospitalization or death, or can make long-term health problems worse.6 Roche has a long heritage in developing medicines that contribute to public health. We are committed to bringing innovation in the field of infectious diseases, including influenza. TamifluTM (oseltamivir) has made a significant difference both to the treatment of seasonal influenza as well as in the management of recent pandemics, and we are proud to have brought this innovative medicine to patients. Although vaccines are an important first line of defence in preventing the flu, there is a need for new medical options for prophylaxis and treatment. Current treatments – including vaccines and antiviral medicines – have limitations as flu viruses are constantly changing and new antiviral medicines are necessary. Roche is committed to addressing the unmet need in this area through its agreement with Shionogi & Co., Ltd. to develop and commercialize baloxavir marboxil.

About Roche in infectious disease

Infectious diseases caused by viral or bacterial pathogens are a major cause of death and morbidity worldwide, and constitute an ever-growing medical need. As such, they form a core area of research and development at Roche, with clinical development programmes focused on Hepatitis B, influenza and multi-drug resistant bacterial infections. We are committed to developing medicines that aim to be transformative, personalised, and accessible.

References

1.World Health Organization. Up to 650 000 people die of respiratory diseases linked to seasonal flu each year [Internet; cited 2018 May 29]. Available from: http://www.who.int/mediacentre/news/releases/2017/seasonal-flu/en/.

2.World Health Organization. Influenza (Seasonal) [Internet; cited 2018 May 29]. Available from: http://www.who.int/mediacentre/factsheets/fs211/en.

3.Baxter D. Evaluating the case for trivalent or quadrivalent influenza vaccines. Hum Vaccin Immunother. 2016; 12(10):2712-2717.

4.Centers for Disease Control and Prevention. Estimated Influenza Illnesses, Medical Visits, Hospitalizations, and Deaths Averted by Vaccination in the United States. [Internet; cited 2018 June 06]. Available from: https://www.cdc.gov/flu/about/disease/2015-16.htm

5.Nair H, et al. Global burden of respiratory infections due to seasonal influenza in young children: a systematic review and meta-analysis. Lancet. 2011 Dec 3;378(9807):1917-30.

6.Centers for Disease Control and Prevention. Are you at high risk for serious illness from flu? [Internet; cited 2018 July 03]. Available from: https://www.cdc.gov/features/fluhighrisk/index.html

7.T. Noshi et al. S-033447/S-033188, a Novel Small Molecule Inhibitor of Cap-dependent Endonuclease of Influenza A and B Virus: In Vitro Antiviral Activity against Laboratory Strains of Influenza A and B Virus in Madin-Darby Canine Kidney Cells. Poster presentation at OPTIONS IX, August 2016

8.K.Taniguchi et al. Inhibitory Effect of S-033188, a novel inhibitor of influenza virus cap-dependent endonuclease, against avian influenza A/H7N9 virus in vitro and in vivo. Poster presentation at ESWI, September 2017.

9.K.Taniguchi et al. Inhibitory Effect of S-033188/S-033447, a novel inhibitor of influenza virus cap-dependent endonuclease, against highly pathogenic avian influenza virus A/H5N1. Poster presentation at ECCMID, April 2017.

10.Shi et al. Viral RNA polymerase: a promising antiviral target for influenza A virus. Curr Med Chem. 2013;20(31):3923–34.

11.Kawaguchi et al. Effects of S-033188, a cap-dependent endonuclease inhibitor, on influenza symptoms and viral titer: Results from a phase 2, randomized, double-blind, placebo-controlled study in otherwise healthy adults with seasonal influenza. Poster presented at ESWI 2017.

Roche er en global pioner innen legemidler og diagnostikk som fremmer medisinsk vitenskap og forbedrer menneskers liv. Den kombinerte styrken ved å ha legemidler og diagnostikk under ett tak, har gjort Roche ledende innen persontilpasset medisin – en strategi som tar sikte på å tilpasse behandlingen til den enkelte pasient på best mulig måte.

Roche er verdens største bioteknologiselskap med medisiner innen onkologi, immunologi, infeksjonssykdommer, oftalmologi og nevrologi. Roche er også verdensledende innen in vitro-diagnostikk, vevsbasert kreftdiagnostikk og diabetesbehandling.

Siden grunnleggelsen i 1896 har Roche forsket etter bedre måter å forebygge, diagnostisere og behandle sykdommer på, og bidra til en bærekraftig samfunnsutvikling. Selskapet har som mål å forbedre pasienters tilgang til medisinsk innovasjon ved å samarbeide med alle relevante interessenter.

Roche har utviklet 30 medisiner som inngår i Verdens helseorganisasjons liste over essensielle legemidler, blant dem livreddende antibiotika, antimalariamedisin og kreftmedisin. For niende året på rad er Roche anerkjent i Dow Jones Sustainability Index som det mest bærekraftige selskapet innen legemidler, bioteknologi og livsvitenskap.

Roche har hovedkvarter i Basel, Sveits og har 94 000 medarbeidere i mer enn hundre land. I 2017 investerte Roche 87 milliarder norske kroner i forskning og utvikling av et totalt salg på 447 milliarder norske kroner. Genentech i USA er et heleid selskap av Roche. Roche er også majoritetseier i Chungai Pharmaceutical, Japan. For mer informasjon, se www.roche.com.

Alle varemerker brukt eller nevnt i denne meldingen er beskyttet ved lov.

-Baloxavir marboxil is the first flu medicine with a novel proposed mechanism of action in nearly 20 years and to demonstrate significant efficacy in high-risk patients. -Influenza represents a serious threat to public health. Globally, annual epidemics result in 3 to 5 million cases of severe disease, millions of hospitalizations and up to 650,000 deaths worldwide.

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Positive fase III-data for Roches immunterapi Tecentriq(R)▼ innen trippel-negativ brystkreft med spredning

Pressemeldinger   •   jul 02, 2018 15:25 CEST

- IMpassion130-studien er den første fase III-studien med immunterapi som har vist at Tecentriq (atezolizumab) gir en statistisk signifikant forbedring i progresjonsfri overlevelse (PFS) hos pasienter med avansert trippel-negativ brystkreft. Denne positive effekten var sett uavhengig av PD-L1 uttrykk. - Foreløpig analyse av totaloverlevelse (OS) viste lovende data for PD-L1-positive pasienter.

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Om Roche Norge

Roche - en global pioner innen legemidler og diagnostikk

Den kombinerte styrken ved å ha legemidler og diagnostikk under ett tak, har gjort Roche ledende innen persontilpasset medisin – en strategi som tar sikte på å tilpasse behandlingen til den enkelte pasient på best mulig måte.

Roche er verdens største bioteknologiselskap med medisiner innen onkologi, immunologi, infeksjonssykdommer, oftalmologi og nevrologi. Roche er også verdensledende innen in vitro-diagnostikk, vevsbasert kreftdiagnostikk og diabetesbehandling.

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  • Roche Norge
  • Brynsengfaret 6b
  • 0667 Oslo
  • Norge

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