Novartis Secures FDA Priority Review For Brolucizumab Thanks To PRV

Novartis AG's brolucizumab for wet age-related macular degeneration (AMD) could be on the US market by the end of the year after FDA granted the biologic license application a priority review. Novartis used a priority review voucher (PRV) to expedite the review, the company said while announcing the BLA was accepted for review April 15.

This is the second PRV Novartis has benefited from recently. The company used one for the FDA review of Mayzent (siponimod), which was approved by FDA for multiple sclerosis in late March. (Also see "FDA Backs Novartis MS Pill Mayzent With Broad Label" - Scrip, 27 March, 2019