FDA

Biologics and New Drug Approvals: The Latest Trends
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FDA

How are biologics faring in terms of new drug approvals? DCAT Value Chain Insights examines biologic-based APIs approved as new molecular entities by the FDA’s Center for Drug Evaluation and Research thus far in 2020 and recent trends.

Biologics and NME approvals

Over the past several years, biologics have accounted for 20% to 29% of approvals of new molecular entities (NMEs) by the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER). As of October 1, 2020, FDA’s CDER had approved 40 NMEs. Of these 40 NME approvals thus far in 2020, nine, or 23%, were biologics.

This level of biologic NME approvals by the FDA’s CDER is compatible with 2019 biologic NME approvals. In 2019, small molecules accounted for 79% of all NME approvals, representing 38 of the 48 NMEs approved by the FDA in 2019 and biologics accounted for 10 of the 48 NMEs approved or 21%. In 2018, small molecules accounted for 71% of NME approvals and biologics 29%. In 2017, the product mix between small molecules and biologics was 74% and 26%, respectively; in 2016, the product mix of NME approvals was 68% (small molecules) and 32% biologics, and in 2015, the product mix was 71% (small molecules) and 29% (biologics).

Biologics approved thus far in 2020

Several large pharmaceutical companies have received FDA approval for biologic-based NMEs thus far in 2020. GlaxoSmithKline received approval for Blenrep (belantamab mafodotin-blmf) for treating multiple myeloma. Sanofi received approval for Sarclisa (isatuximab-irfc) for treating multiple myeloma. Specifically, the drug was approved in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Novo Nordisk received approval for Sogroya (somapacitan-beco), a human growth hormone analog indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency.

In addition, Roche received approval for Enspryng (satralizumab-mwge) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular antibody – patients who are anti-aquaporin-4 or AQP4 antibody-positive. NMOSD is a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. A smaller company, Viela Bio, also received approval for a biologic NME for treating NMOSD for Uplizna (inebilizumab-cdon).

Among mid-tier companies, Lundbeck received approval for Vyepti (eptinezumab-jjmr) to prevent migraines. Among  smaller companies, MorphoSys and Incyte received approval for Monjuv (tafasitamab-cxix) in combination with lenalidomide for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma. Immunomedics received approval for Trodelvy (sacituzumab govitecan-hziy) for treating adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease. Horizon Therapeutics received approval for Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards (proptosis).

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