Novartis Gets FDA Nod for Brolucizumab Biologics License Application

April 17, 2019

Novartis has announced that FDA has accepted its biologics license application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD).

Novartis has announced that FDA has accepted its biologics license application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD).

The application is predominantly based on data from the Phase III HAWK and HARRIER trials, which are global head-to-head trials comparing the efficacy and safety of intravitreal injection of brolucizumab with that of aflibercept. To speed up the review process, Norvatis has revealed in an April 15, 2019 press release that it has utilized a priority review voucher.

“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.”

“Wet AMD robs people of their precious sight and takes a major toll on the lives of millions of people who face not only vision loss, but also the burden of frequent injections into their eyes,” added Dawn Prall George, executive director, The Support Sight Foundation. “We are always excited about potential new treatment options and hopeful they may help people manage this devastating disease.”

If brolucizumab receives FDA approval, Novartis estimates it will be able to launch the product by the end of 2019.

Source: Novartis