2021 FDA TIDES (Peptides and Oligonucleotides) Harvest

Abstract

From the medical, pharmaceutical, and social perspectives, 2021 has been a year dominated by the COVID-19 pandemic. However, despite this global health crisis, the pharmaceutical industry has continued its endeavors, and 2021 could be considered an excellent year in terms of the drugs accepted by the US Food and Drug Administration (FDA). Thus, during this year, the FDA has approved 50 novel drugs, of which 36 are new chemical entities and 14 biologics. It has also authorized 10 TIDES (8 peptides, 2 oligonucleotides), in addition to 2 antibody-drug conjugates (ADCs) whose structures contain peptides. Thus, TIDES have accounted for about 24% of the approvals in the various drug categories. Importantly, this percentage has surpassed the figure in 2020 (10%), thus reflecting the remarkable success of TIDES. In this review, the approved TIDE-based drugs are analyzed on the basis of their chemical structure, medical target, mode of action, administration route, and adverse effects.

Clinical management and emerging therapies of FGFR3-related skeletal dysplasia in childhood

“…In 2021, the FDA approved a C-type natriuretic peptide (CNP) analog, vosoritide, to increase height in ACH individuals aged ≥5 years whose epiphyses are not closed. 51)…”

“…It is recommended that this invasive procedure be postponed until the patient can make an informed decision. In 2021, the FDA approved a C-type natriuretic peptide (CNP) analog, vosoritide, to increase height in ACH individuals aged ≥5 years whose epiphyses are not closed [ 51 ].…”

Advances in solid-phase peptide synthesis in aqueous media (ASPPS)

“…10 Of note, 22 peptides have been approved by the FDA over the last six years, either as peptide-based drugs or as payloads and/or linkers in antibody–drug conjugates (ADCs). 11…”

In situ Fmoc removal – a sustainable solid-phase peptide synthesis approach

“…As an example, in 2021, the US Food and Drug Administration (FDA) approved ten drugs containing peptides, a number that accounts for 25% of the 2021 drug harvest. 5 In the context of green chemistry, SPPS has large "green brushstrokes". In this regard, this strategy has the following characteristics: [6][7][8] (i) all reactions are carried out in the same reactor, with no mass transfer between reactors, and no major cleaning procedures; (ii) intermediates are not isolated, thereby lowering solvent consumption; (iii) excellent yields are obtained, which facilitates purification and reduces the use of solvents; (iv) high boiling point solvents are used; (v) solvents can be recycled and the resin can be reused [when a chlorotrityl chloride (CTC) resin is used]; (vi) excess reactants and soluble side products are removed by simple filtration and washing with the corresponding solvents; and, finally, (vii) high efficiency and reduced labor hours are achieved.…”