2023 was a big year for hematology, neurology and oncology, with the medical specialties seeing the most FDA approvals. In terms of sponsors, Pfizer had the most approvals with six total, followed by UCB and Chiesi, each with three apiece.
When looking at commercial prospects, AstraZeneca’s respiratory syncytial virus antibody Beyfortus could be the biggest blockbuster from the 2023 cohort with expected peak sales of $1.9 billion. Alzheimer’s drug Leqembi could also be a major success, making up for the tepid demand for Aduhelm, which won conditional approval in 2021. While Aduhelm’s sales have sputtered, Leqembi could see peak revenue of $4.8 billion according to analysts.
Oncology continues to be a hot specialty with the most competition among the newly approved drugs, as the FDA continues to green light new entrants in crowded target classes such as PD-1 inhibitors.
In 2023, Pfizer received FDA approval for a half dozen drugs across a range of medical specialties, including zavegepant (Zavzpret), a CGRP receptor antagonist used for migraine. The company also scored full approval for nirmatrelvir, ritonavir (Paxlovid), a SARS-CoV-2 main protease inhibitor plus a CYP3A inhibitor used to treat mild-to-moderate COVID-19. Rounding out the approvals were ritlecitinib (Litfulo), a JAK3 inhibitor for alopecia areata; somatrogon (Ngenla), a human growth hormone analogue for growth hormone deficiency; elranatamab (Elrexfio), a BCMA × CD3 T-cell engager for multiple myeloma; and etrasimod (Velsipity), an S1P receptor modulator for ulcerative colitis.
Belgian pharma company UCB scored approvals for three new meds in 2023, including rozanolixizumab (Rystiggo), an FcRn-targeted monoclonal antibody for generalized myasthenia gravis patients who are acetylcholine receptor- or MuSK-antibody-positive; zilucoplan (Zilbrysq), a complement C5 inhibitor for acetylcholine receptor-positive generalized MG; and bimekizumab (Bimzelx), an IL-17A/F-targeted monoclonal antibody for plaque psoriasis.
Also scoring three approvals was the Italian pharma Chiesi, including velmanase alfa (Lamzede), a recombinant α-mannosidase for non-CNS manifestations of α-mannosidosis; pegungalsidase alfa (Elfabrio), a PEGylated recombinant α-galactosidase Α for Fabry disease; and birch triterpenes (Filsuvez), a treatment for epidermolysis bullosa.