BioPharm International - September 2022

BioPharm International - September 2022

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26 BioPharm International ® Emerging Therapies 2022 eBook W hen attempting to gauge the future of emerging therapies, it's important to also look to the past for clues on what may be lurking beyond the horizon. Knowledge of what FDA has approved in the past is in- strumental not only in understanding the current reg- ulatory landscape, but also in determining the types of therapies that are likely to be approved going forward. Of the 16 novel molecular entities and therapeutic biological products that have been approved by FDA in 2022 at the time of this article's writing, the three discussed in this article are all but one of the biolog- ics (1). While this is a significant decrease from 2021, which saw four biologics approved in November and December alone, it is notable that novel approvals as a whole are down significantly; at this time last year, there were 35 total approvals (i.e. both new drug appli- cations and biologic license applications) approved (2). While there are many reasons why such a decrease can occur, including simple random chance, it none- theless places greater emphasis on what therapies are getting through the approvals process. Examining the biologics that are getting through could provide a baseline for the requirements needed to get through future approval processes. Roche's multiple eye disease treatment Just days after the approval of tebentafusp-tebn, FDA approved Vabysmo (faricimab-svoa) for treatment of wet age-related macular degeneration (AMD) and dia- betic macular edema (DME). The indication, which was granted to Genentech, a Roche group company, on Jan. 28, 2022, is the first granted to a bispecific antibody for treatment of the eye (3). TENAYA and LUCERNE are two identical, random- ized, multicenter, double-masked, globa l studies evaluating the efficacy and safety of faricimab-svoa compared to aflibercept in 1329 people living with wet AMD (671 in TENAYA and 658 in LUCERNE). The pri- mary endpoint of both studies was based on average Novel Therapies of 2022 Grant Playter, assistant editor Looking back at the biologics and large molecule drugs approved by FDA in the past year can give us hints toward what will be approved in the future. AKSANA K AVALEUSK AYA - STOCK.ADOBE.COM

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