Nine Major Approval Decisions To Watch In Early 2022
Nine prominent drug candidates are awaiting an FDA approval decision in the next few months. With the help of Biomedtracker's Early 2022 Outlook Report, we take a look at the potential launches likely to shake up the market from HIV to wet AMD.
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The LAG-3 antibody relatlimab, with Opdivo in the fixed-dose combo Opdualag and a $27,389-per-dose price, is the first approved in a new class of checkpoint inhibitors since the anti-PD-1/PD-L1s.
The company published data for the bispecific antibody in wet AMD and DME, with non-inferior efficacy to Eylea and growing support for less frequent administration.
The company presented 18-month data at a conference that it thinks will support strong uptake. European regulators required the 18-month data for filing; an FDA decision based on 9-month data is expected in April.