FDA accepts Novartis' brolucizumab filing for patients with wet AMD

Novartis announced Monday that the FDA has accepted its marketing application for brolucizumab, also known as RTH258, for the treatment of wet age-related macular degeneration (AMD). The company said it used a priority review voucher to expedite the review process, adding that if approved, it anticipates launching the humanised single-chain antibody fragment in the US by the end of 2019.

Novartis explained that its submission of the therapy was primarily based on data from the Phase III HAWK and HARRIER studies. Results unveiled last October showed that brolucizumab was superior to Regeneron Pharmaceuticals' Eylea (aflibercept) at reducing retinal fluid, which followed data reported in 2017 illustrating that the treatment was non-inferior to Eylea regarding best corrected visual acuity at 48 weeks.

"Reaching this milestone is an important step in our efforts to reimagine the treatment journey for people with wet AMD and their caregivers," remarked Fabrice Chouraqui, president of Novartis Pharmaceuticals Corporation, adding "we are looking forward to the potential of a new option for patients with wet AMD."

The news comes after Novartis completed the separation of its Alcon eye care devices business into a standalone company earlier this month. The Swiss drugmaker elected to spin off the division last year to focus on its pharmaceuticals business.


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