Schlieren ZH/Basel – The U.S. Food and Drug Administration (FDA) will process the regulatory application for brolucizumab as quickly as possible. The drug for the treatment of wet age-related macular degeneration was originally developed in the Bio-Technopark Schlieren.
Novartis has announced FDA filing acceptance and priority review of brolucizumab in a press release. “We are proud that both Phase III studies with brolucizumab were successfully completed and hope that this treatment will soon become available for all patients with neovascular age-related macular degeneration,” said Dominik Escher in an article on transkript.de.
Dominik Escher was among the co-founders of the Schlieren-based company Esbatech when it was spun-out from the University of Zurich (UZH) in 1998. Esbatech started and advanced the development of brolucizumab. In 2009, Esbatech, also one of the founding members of the Bio-Technopark Schlieren-Zurich, was taken over by U.S. company Alcon, which was in turn fully acquired by Novartis in 2010. Although Novartis recently completed the spin-out of Alcon, brolucizumab remained with the Basel pharma giant. According to the press release, it expects to launch brolucizumab by the end of 2019, once approved by the FDA. “This will be the first single-chain antibody fragment (scFv) to come to market and therefore open up a new product class,” explained Escher. “Esbatech carried out pioneering work for this product class and I hope that many patients will benefit from this in the future.” Escher is now President of the Swiss Biotech Association and Partner of BB Pureos Bioventures, an investment company based in Küsnacht ZH that advances drug development.
Novartis reports that wet age-related macular degeneration is the leading cause of severe vision loss and legal blindness in people over the age of 65. It is estimated to affect 20 to 25 million people worldwide.