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Novartis announces FDA filing acceptance and Priority Review of brolucizumab (RTH258) for patients with wet AMD

Nachrichtenquelle: GlobeNewswire
15.04.2019, 22:05  |  426   |   |   

Novartis International AG / Novartis announces FDA filing acceptance and Priority Review of brolucizumab (RTH258) for patients with wet AMD . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

  • By 2020, over 1.5 million people in the US are likely to have wet AMD, the leading cause of blindness in industrialized countries
     
  • Filing is based on Phase III data from the HAWK and HARRIER trials for brolucizumab
     
  • Novartis used a priority review voucher to expedite review of brolucizumab in the US and, if approved by FDA, anticipates launching by the end of 2019
  • Basel, April 15, 2019 - Novartis announced that the US Food and Drug Administration (FDA) accepted the company's Biologics License Application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD), also known as neovascular AMD, or nAMD. Seeking to make brolucizumab available as quickly as possible, Novartis used a priority review voucher to expedite FDA review. If approved by the FDA, Novartis anticipates launching brolucizumab by the end of 2019.

    Estimates suggest that by 2020, 1.5 to 1.75 million people in the US will be living with wet AMD, a leading cause of blindness worldwide and a rapidly growing public health concern[1]. As the disease progresses, patients may experience loss of central vision, resulting in an inability to complete daily tasks. Without treatment, vision can rapidly deteriorate and may lead to blindness[2].

    "Reaching this milestone is an important step in our efforts to reimagine the treatment journey for people with wet AMD and their caregivers," said Fabrice Chouraqui, President, Novartis Pharmaceuticals Corporation. "We are looking forward to the potential of a new option for patients with wet AMD, who often have to navigate considerable physical and emotional difficulties caused by deteriorating vision."

    The regulatory application is primarily based on Phase III data from the HAWK and HARRIER trials - prospective, randomized, double-masked multi-center studies[3],[4]. The primary endpoint of these studies was non-inferiority to aflibercept in mean change in best-corrected visual acuity (BCVA) from baseline to week 48 (mean change in BCVA of 6.6 letters for brolucizumab 6 mg versus 6.8 letters for aflibercept in HAWK and 6.9 letters versus 7.6 letters, respectively, in HARRIER). HAWK and HARRIER are the first and only global head-to-head trials in patients with wet AMD that prospectively demonstrated efficacy at week 48 starting with a 12-week dosing regimen.

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