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    ROG   CH0012032048

ROCHE HOLDING AG

(ROG)
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Press Release : FDA accepts application for Roche's faricimab for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME)

07/29/2021 | 01:03am EDT
   -- Across four phase III studies, approximately half of patients receiving 
      faricimab could extend treatment time to every four months -- the first 
      time this level of durability has been achieved in phase III nAMD and DME 
      studies 
 
   -- If approved, faricimab would be the first and only medicine designed to 
      target two distinct pathways that drive retinal diseases that can cause 
      vision loss 
 
   -- The European Medicines Agency has also validated the faricimab Marketing 
      Authorisation Application submission in nAMD and DME 

Basel, 29 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA), under Priority Review, for faricimab for the treatment of neovascular or "wet" age-related macular degeneration (nAMD) and diabetic macular edema (DME). The FDA has also accepted the company's submission for diabetic retinopathy.

Faricimab will be the first and only bispecific antibody designed for the eye, if approved. It targets two distinct pathways -- via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) -- that drive a number of retinal conditions that can cause vision loss.(1)

"If approved, faricimab would be the first in a new class of eye medicines targeting two key pathways that drive retinal disorders, with the potential to offer durable vision outcomes with fewer eye injections than the current standard of care," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. "Therefore, we hope faricimab will become a new treatment option for millions of people living with nAMD and DME."

Neovascular AMD and DME are two leading causes of vision loss among adults worldwide.(2) The BLA submission is based on positive results across four phase III studies in nAMD and DME. The studies consistently showed that faricimab, given at intervals of up to four months, offered non-inferior vision gains compared with aflibercept, given every two months. Approximately half of people eligible for extended dosing with faricimab were able to be treated every four months in the first year in the TENAYA and LUCERNE studies in nAMD and the YOSEMITE and RHINE studies in DME. Faricimab is the first injectable eye medicine to achieve this length of time between treatments in phase III studies for nAMD and DME. Furthermore, approximately three-quarters of people eligible for extended dosing with faricimab were able to be treated every three months or longer in the first year. Faricimab was generally well-tolerated in all four studies, with no new or unexpected safety signals identified.(3) (,4)

Roche also has long-term extension studies underway for faricimab. These include AVONELLE X, an extension study of TENAYA and LUCERNE evaluating the long-term safety and efficacy of faricimab in nAMD, and RHONE X, an extension study of YOSEMITE and RHINE evaluating the long-term safety and efficacy of faricimab in DME.(5,6) Additionally, the COMINO and BALATON trials are also underway, evaluating the efficacy and safety of faricimab in people with macular edema secondary to two types of retinal vein occlusion (RVO): central RVO and branch RVO.(7,8)

The European Medicines Agency has also validated the faricimab Marketing Authorisation Application for the treatment of nAMD and DME.

About the TENAYA and LUCERNE Studies(3)

TENAYA (NCT03823 https://www.globenewswire.com/Tracker?data=sgZMijAsLvvBpdhoK_xmWbIdBf6jw3zCapihhvtztYW2r_CqWcie0zX_I8C1Fa_hLmXoW1iZ9ngUxqY5gkzs5K4d4Pi8JL23dUpMX_Ge-zDybAjUkmrInpIu3Cbi4Z5U6ZwKm6EwVO0i8DqmULH3QQ== 287 https://www.globenewswire.com/Tracker?data=MaZNSgLooaOnP2xMt098_DuOJ0q7blT5LeuiXpsllxHbRV05Eup8AvABSmSpfUHvRVqaGw8x6-6BzRHIXskP6HAOSoq-7HXaw0g7L0Uu7NH4mvdrWwn-VdQNCNJhCTVAddIQUqxerNC_DreBoY0u4w== ) and LUCERNE (NCT03823300 https://www.globenewswire.com/Tracker?data=sgZMijAsLvvBpdhoK_xmWbppa8Q4QLVMKg9n9eR_fEnddcOkgJc-kW2_8g2UKfmtMkxi4dnrbM0u8E1YpHxOslIfjDFaS-VDZ59ZwEBuVQjT4_yykaJIShMOrJSoGgAs8cJBKL_FZJ1fCxt-P_iGpQ== ) are two identical, randomised, multicentre, double-masked, global phase III studies evaluating the efficacy and safety of faricimab compared to aflibercept in 1,329 people living with neovascular age-related macular degeneration (671 in TENAYA and 658 in LUCERNE). The studies each have two treatment arms: faricimab 6.0 mg administered at fixed intervals of every two, three, or four months, selected based on objective assessment of disease activity at weeks 20 and 24; and aflibercept 2.0 mg administered at fixed two-month intervals. In both arms, sham injections were administered at study visits when treatment injections were not scheduled, to maintain the masking of investigators and participants.

The primary endpoint of the studies is the average change in best-corrected visual acuity (BCVA) score (the best distance vision a person can achieve -- including with correction such as glasses -- when reading letters on an eye chart) from baseline through week 48. Secondary endpoints include: safety; the percentage of participants in the faricimab arm receiving treatment every two, three and four months; the percentage of participants achieving a gain, and the percentage avoiding a loss, of 15 letters or more in BCVA from baseline over time; and change in central subfield thickness (CST) from baseline over time.

Both studies met their primary endpoint, with faricimab consistently shown to offer non-inferior visual acuity gains to aflibercept. In TENAYA and LUCERNE, the average vision gains from baseline in the faricimab arms were +5.8 and +6.6 letters, respectively, compared to +5.1 and +6.6 letters in the aflibercept arms.

The studies also measured the proportion of people in the faricimab arm that were treated on dosing schedules of every three or four months during the first year. Importantly, 46% (n=144/315) of patients in TENAYA and 45% (n=142/316) in LUCERNE were able to be treated every four months in the first year. An additional 34% (n=107/315) of patients in TENAYA and 33% (n=104/316) in LUCERNE were able to be treated every three months. Combined, nearly 80% of faricimab-treated patients were able to go three months or longer between treatments during the first year. In both studies, faricimab given at intervals of up to four months offered reductions in CST comparable to aflibercept given every two months. Faricimab was generally well-tolerated in both studies, with no new or unexpected safety signals identified.

About the YOSEMITE and RHINE Studies(4)

YOSEMITE (NCT03622580) and RHINE (NCT03622593) are two identical, randomised, multicentre, double-masked, global phase III studies evaluating the efficacy and safety of faricimab compared to aflibercept in 1,891 people with diabetic macular edema (940 in YOSEMITE and 951 in RHINE). The studies each have three treatment arms: faricimab 6.0 mg administered at personalised treatment intervals (PTI) of up to four months; faricimab 6.0 mg administered at fixed two-month intervals; and aflibercept 2.0 mg administered at fixed two-month intervals. In all three arms, sham injections were administered at study visits when treatment injections were not scheduled, to maintain the masking of investigators and participants.

The primary endpoint of the studies is the average change in best-corrected visual acuity (BCVA) score from baseline at one year. Secondary endpoints include: safety; the percentage of participants in the personalised dosing arm receiving treatment every one, two, three and four months, at week 52; the percentage of participants achieving a two-step or greater improvement from baseline in diabetic retinopathy severity at week 52; the percentage of participants achieving a gain, and the percentage avoiding a loss of 15 letters or more in BCVA from baseline over time and change in central subfield thickness (CST) from baseline over time.

Both studies met their primary endpoint with faricimab consistently shown to offer non-inferior visual acuity gains to aflibercept. In YOSEMITE, the average vision gains from baseline were +11.6 and +10.7 eye chart letters in the faricimab PTI and two-month arms, respectively, and +10.9 letters in the aflibercept arm. In RHINE, the average vision gains from baseline were +10.8 and +11.8 letters in the faricimab PTI and two-month arms, respectively, and +10.3 letters in the aflibercept arm.

A secondary endpoint in both studies measured the proportion of people in the faricimab PTI arm that achieved dosing schedules of every three or four months at the end of the first year. Importantly, 53% (n=151/286) of faricimab PTI patients in YOSEMITE and 51% (n=157/308) in RHINE achieved four-month dosing at one year. An additional 21% (n=60/286) of faricimab PTI patients in YOSEMITE and 20% (n=62/308) in RHINE achieved three-month dosing. Combined, more than 70% of faricimab PTI patients were able to go three months or longer between treatments at the end of the first year. In both studies, faricimab given at intervals of up to four months demonstrated greater reductions in CST compared to aflibercept given every two months. Faricimab was generally well-tolerated in both studies, with no new or unexpected safety signals identified.

About neovascular age-related macular degeneration

Age-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading.(9) Neovascular or "wet" AMD (nAMD) is an advanced form of the disease that can cause rapid and severe vision loss.(10) It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis.(11) Worldwide, around 20 million people are living with nAMD -- the leading cause of vision loss in people over the age of 60 -- and the condition will affect even more people around the world as the global population ages.(9,12,13)

About diabetic macular edema

(MORE TO FOLLOW) Dow Jones Newswires

July 29, 2021 01:03 ET (05:03 GMT)

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Sales 2021 61 371 M 66 361 M 66 361 M
Net income 2021 14 747 M 15 945 M 15 945 M
Net cash 2021 4 289 M 4 637 M 4 637 M
P/E ratio 2021 19,8x
Yield 2021 2,76%
Capitalization 298 B 322 B 322 B
EV / Sales 2021 4,78x
EV / Sales 2022 4,61x
Nbr of Employees 101 465
Free-Float 83,5%
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