Late-breaking data for Roche ’s BTK inhibitor fenebrutinib show brain penetration and significant reduction in lesions in patients with relapsing multiple sclerosis
New data from Phase II FENopta study in relapsing multiple sclerosis (RMS) show fenebrutinib crosses the blood-brain barrier with the potential to act directly on the chronic inflammation related to multiple sclerosis (MS)More than 90% relative reduction in new/enlarging T2 lesions and new T1 gadolinium-enhancing (Gd+) lesions with fenebrutinib beginning at 8 weeksThe safety profile of fenebrutinib was consistent with previous and ongoing clinical trials across more than 2,500 people to dateBasel, 13 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new data from the Phase II FENopta study showing that inve...
Source: Roche Media News - October 13, 2023 Category: Pharmaceuticals Source Type: news
New data for Roche ’s OCREVUS show that after 10 years of treatment 77% of people with relapsing multiple sclerosis were free from disability progression and 92% continue to walk unaided
10-year efficacy data highlight OCREVUS ’ impact on preventing disability progression and maintaining mobility in both relapsing and progressive forms of multiple sclerosis (MS)10-year safety data from over 6,000 patients continue to reinforce consistent long-term safety profile of OCREVUSMore than 3,200 women with MS treated with OCREVUS reported no increased risk in adverse pregnancy and infant outcomes with real-world analyses showing low risk of relapse during and after pregnancyOCREVUS controlled disease activity and progression over one year in Black and Hispanic / Latinx people with MSBasel, 12 October 2023 - Roch...
Source: Roche Media News - October 12, 2023 Category: Pharmaceuticals Source Type: news
Roche ’s OCREVUS twice-yearly, 10-minute subcutaneous injection was non-inferior to intravenous infusion and provided near-complete suppression of brain lesions
Late-breaking Phase III results show subcutaneous injection was non-inferior to intravenous infusion based on OCREVUS levels in the blood over 12 weeksOCREVUS subcutaneous injection was comparable to IV infusion in providing rapid and sustained depletion of B cells and near-complete suppression of MRI lesion activity in the brain over 24 weeksThe safety profile of OCREVUS subcutaneous injection was consistent with the well-established safety profile of OCREVUS IV infusionThe 10-minute subcutaneous injection has potential to improve the treatment experience and expand usage for people with multiple sclerosis (MS) in centres...
Source: Roche Media News - October 11, 2023 Category: Pharmaceuticals Source Type: news
Roche ’s Vabysmo maintained vision improvements with extended treatment intervals up to four months for people with retinal vein occlusion (RVO) in phase III studies
Vabysmo showed robust and sustained retinal drying up to 72 weeks and a safety profile consistent with previous studiesRegulatory applications for Vabysmo in RVO are under review by health authorities around the world; if approved, RVO would be the third indication in addition to nAMD and DMEVabysmo is the first and only treatment that targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditionsBasel, 10 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline long-term results from the global phase III BALATON and COMINO studies, evaluating extended tre...
Source: Roche Media News - October 10, 2023 Category: Pharmaceuticals Source Type: news
Majority of newborn babies with spinal muscular atrophy (SMA) treated with Roche ’s Evrysdi able to sit independently after 1 year of treatment
RAINBOWFISH study met its primary endpoint with 80% of babies sitting without support for at least five seconds after 1 year of Evrysdi treatment – without treatment these babies would never be able to sitAll babies were able to swallow and feed orally and none required permanent ventilationEvrysdi is the only non-invasive SMA therapy and is approved in over 100 countries with more than 11,000 patients treated globallyBasel, 04 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented positive results from the primary analysis of the ongoing RAINBOWFISH study assessing the efficacy and safety of Evrysdi ® (risdi...
Source: Roche Media News - October 4, 2023 Category: Pharmaceuticals Source Type: news
Roche to present new key clinical and real-world data at ECTRIMS-ACTRIMS 2023 showcasing strength of long-term outcomes in MS and NMOSD
Late-breaking results from Phase III trial of OCREVUS (ocrelizumab) subcutaneous injection and Phase II trial of BTK inhibitorfenebrutinib in multiple sclerosis (MS) will be presented10-year OCREVUS efficacy and safety data show significant benefit in slowing long-term disability progression and consistent long-term safety profile in MSAdditional OCREVUS real-world and clinical data show impact for underrepresented populations including more than 3,200 pregnant women and Black and Hispanic/Latinx patients with MSLonger-term safety data and late-breaking efficacy data from Phase III trial of ENSPRYNG (satralizumab) inneurom...
Source: Roche Media News - October 2, 2023 Category: Pharmaceuticals Source Type: news
Roche and Alnylam report positive topline results from Phase 2 study KARDIA-1 of zilebesiran, an investigational RNAi therapeutic in development to treat hypertension in patients at high risk of cardiovascular disease
Zilebesiran met primary endpoint demonstrating greater than 15 mmHg reduction of systolic blood pressure at three months of treatment compared to placeboStudy met key secondary endpoints showing consistent and sustained reductions of systolic blood pressure at six monthsZilebesiran demonstrated an encouraging safety and tolerability profile in adult patients with mild-to-moderate hypertensionFull study results to be presented at an upcoming scientific conferenceBasel, 7 September 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Alnylam announced today that the Phase 2 study KARDIA-1 of zilebesiran, an investigational RNAi the...
Source: Roche Media News - September 7, 2023 Category: Pharmaceuticals Source Type: news
Roche ’s Alecensa delivers unprecedented Phase III results for people with ALK-positive early-stage lung cancer
ALINA data demonstrateAlecensa reduces disease recurrence in the early setting for people with ALK-positive non-small cell lung cancer (NSCLC), building on its long-established benefit in the advanced settingAbout half of people with NSCLC experience disease recurrence following surgery, despite adjuvant chemotherapy, therefore new treatments are urgently needed to provide the best chance for cureThese data will be submitted to health authorities globallyand presented at an upcoming medical meetingBasel, 01 September 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Phase III ALINA study evaluating Alecens...
Source: Roche Media News - September 1, 2023 Category: Pharmaceuticals Source Type: news
Roche ’s Tecentriq becomes the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain, reducing treatment time to just minutes
Tecentriq subcutaneous (SC) is now approved in Great Britain for all indications of intravenousTecentriq, including certain types of lung, bladder, breast and liver cancer, offering a faster, more convenient option to receive treatmentAdministered under the skin within approx. seven minutes,Tecentriq SC saves time for patients and helps conserve resources in healthcare systems1Evaluations by the FDA, EMA and other health authorities globally are ongoingBasel, 29 August 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Tecentriq ® SC (atezolizumab) has been approved by the Medicines and Healthcare products Reg...
Source: Roche Media News - August 29, 2023 Category: Pharmaceuticals Source Type: news
European Commission approves Roche ’s Evrysdi for babies under two months old with spinal muscular atrophy (SMA)
Evrysdi available to treat people of all ages with SMA in the European Union, including babies from birth1Approval is based on interim data from ongoing RAINBOWFISH trial showing majority ofEvrysdi-treated babies were able to stand and walk within timeframes typical of healthy babies by 12 months ’ treatment2,3Evrysdi is the only non-invasive SMA therapy and is approved in 100 countries with more than 11,000 patients treated globallyBasel, 29 August 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved the extension of the Evrysdi ® (risdiplam) European Union (EU) marketing ...
Source: Roche Media News - August 29, 2023 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on Phase III Skyscraper-01 study in PD-L1-high metastatic non-small cell lung cancer
Basel, 23 August 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has been made aware of an inadvertent disclosure of the second interim analysis of the Phase III SKYSCRAPER-01 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq ® (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for people with PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC).SKYSCRAPER-01 is ongoing and the study remains blinded to patients and investigators. We are continuing the study until the final analysis for overall survival. All other stud...
Source: Roche Media News - August 23, 2023 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong growth in both divisions ’ base business; Group sales and profit reflect declining demand for COVID-19 products
Basel, 27 July 2023Excluding COVID-19 products,Groupsales increase strongly by 8%1at constant exchange rates (CER)In line with the expected declining demand for COVID-19 products,Groupsales decrease 2% (-8% in Swiss francs)Pharmaceuticals Division sales grow strongly by 8% due to continued high demand for newer medicines; new eye medicine Vabysmo is the strongest growth driverDiagnostics Division ’s base businesscontinues its good growth momentum with an increase of 6%, while total divisional sales are 23% lower due to exceptionally high demand for COVID-19 tests in the first half of 2022Core earnings per share decrease ...
Source: Roche Media News - July 27, 2023 Category: Pharmaceuticals Source Type: news
Roche enters partnership with Alnylam to co-develop and co-commercialise RNAi therapeutic zilebesiran to treat hypertension in patients with high cardiovascular risk
Partnership combines Roche ’s proven track record of successfully developing and launching innovative medicines worldwide withAlnylam ’s leadership in RNAi therapeuticsZilebesiran, a Phase 2 RNAi therapeutic, has best-in-disease potential for patients with hypertension at high risk of cardiovascular morbidity and mortality, by robustly and durably lowering blood pressureHypertension, the leading cause of cardiovascular disease, affects more than 1.2 billion adults worldwide. While several therapies exist, a significant unmet need, especially for high risk patients, remains.1Basel, 24 July 2023 - Roche (SIX: RO, ROG; OT...
Source: Roche Media News - July 24, 2023 Category: Pharmaceuticals Source Type: news
CHMP recommends Roche ’s Evrysdi for babies under two months old with spinal muscular atrophy (SMA)
Positive recommendation is based on interim data from ongoing RAINBOWFISH trial which showed majority ofEvrysdi-treated babies were able to stand and walk within timeframes typical of healthy babies by 12 months ’ treatment1,2If approved by the European Commission,Evrysdi will be available to treat people of all ages with SMA in the European Union, including babies from birthEvrysdi is now approved in 100 countries with more than 8,500 patients treated globallyBasel, 21 July 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive o...
Source: Roche Media News - July 21, 2023 Category: Pharmaceuticals Source Type: news
New clinical and real-world data for Roche ’s Vabysmo at ASRS reveal improved outcomes for people with two leading causes of vision loss
Late-breaking post-hoc data indicateVabysmo leads to less fibrosis, which may negatively impact vision, thanaflibercept in people with diabetic macular edema (DME)Real-world data reinforce that first-lineVabysmo use improves outcomes and extends treatment intervals rapidly during the first four months for people withneovascular or ‘wet’ age-related macular degeneration (nAMD) and DMEClinical data reiterateVabysmo ’s positive anatomical outcomes, including reduced blood vessel leakage in the macula and greater and faster retinal fluid controlVabysmo is currently approved in over 70 countries to treatnAMD and DME, with...
Source: Roche Media News - July 20, 2023 Category: Pharmaceuticals Source Type: news
