Biotech Sponsors Dominate 2024 FDA Approvals
Biotech sponsors accounted for almost two thirds of FDA approvals in 2024 – a significant shift from the prior year, when big or mid-sized pharma names sat behind just over half of approvals.
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Small molecules also regained some of the ground lost to biologics, accounting for 56% of new approvals, up from just half the prior year – a sign that orally-available drugs still have their place despite the shorter exclusivity period granted to them in the 2021 Inflation Reduction Act.
Source: FDA (CDER and CBER approvals); excludes diagnostics and esthetic drug.
* includes Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) approvals in 2024; excludes diagnostics and one estethic treatment.
There were fewer surprises on other counts. There were 61 approvals in total, of which we have included 54* in this analysis (see note - right). These figures represent close to a ten-year average; a re-balancing, perhaps, after 2023’s exceptionally high count (71)- and 2022’s unusual low (39). Cancer still dominates, with 17 new drugs, including 6 of the 10 Accelerated Approvals and three cell therapies. But auto-immune, hematological, infectious and metabolic/endocrine conditions each gained a half-dozen new therapies, there was a quartet of CV approvals and 2024 also welcomed two CNS newcomers, Bristol Myers Squibb’s Cobenfy for schizophrenia and Eli Lilly’s donanemab for Alzheimer’s disease. (See Chart 1 & Table 1)
The new Trump administration raises questions for 2025’s FDA. Trump’s nomination of Harvard physician Marty Makary as FDA Commissioner was less controversial than other nominations (such as Robert Kennedy Jr. as HHS Secretary). But the new US government’s apparent urge to disrupt and streamline could impact FDA staffing levels and/or approval timelines. CDER director Patrizia Cavazzoni announced her resignation in early January 2025, following that of deputy head Namandjé Bumpus in December.
Source: FDA
Drug
Indication
Mechanism of Action
Sponsor
Rezdiffra (resmetirom)
MASH
Thyroid hormone receptor beta agonist
Madrigal Pharmaceuticals
Cobenfy (xanomeline-trospium)
Schizophrenia
Muscarinic receptor agonist/antagonist
Bristol Myers Squibb
Kisunla (donanemab)
Alzheimer’s disease
Anti-amyloid beta antibody
Eli Lilly
Alyftrek (vanza-,teva-, deutivacaftor)
Cystic fibrosis
CFTR modulator
Vertex
Ebglyss (lebrikizumab)
Atopic dermatitis
IL-13 antagonist
Winrevair (sotatercept)
Pulmonary arterial hypertension
Activin signalling inhibitor
Merck & Co.
Leqselvi (deuruxolitinib)
Alopecia areata
Janus kinase inhibitor
Sun Pharma
Ohtuvayre (ensifentrine)
COPD
Phosphodiesterase 3/4 inhibitor
Verona Pharma
Tryvio (aprocitentan)
Hypertension (adjunctive treatment)
Dual endothelin receptor antagonist
Idorsia
Attruby (acoramidis)
ATTR-CM
TTR stabilizer
BridgeBio
Tryngolza (olezarsen)
Familial chylomicronemia syndrome
apoC-III-targeted oligonucleotide
Ionis Pharmaceuticals
Amtagvi (lifileucel)
Metastatic melanoma
TIL-based cell therapy
Iovance Biotherapeutics
Tecelra (afamitresgene autoleucel)
Synovial sarcoma
T-cell receptor cell therapy
Adaptimmune
Aucatzyl (obecabtagene autoleucel)
B-cell acute lymphoblastic leukemia
CAR-T cell therapy
Autolus
