2021 Large Molecule Drug Approvals Review

together with Jen Huen, Naveed Yasin, Becca Burnham, Arathi Chintireddy, and Adrian Parodi

This high-level overview of 2021’s novel large molecule drug approvals is the 2nd in a series of focus articles on 2021’s new drugs (see the small molecules here). You can find our deep-dive on 2021’s large molecule drug approvals here.

There were:

  • 50 novel drugs approved in 2021
  • 16 large molecules drugs (not including biosimilars or vaccines)

Of the novel large molecule drugs, there were:

  • 6 monoclonal antibodies (mAbs)
  • 4 recombinant proteins
  • 2 antibody-drug conjugates (ADCs)
  • 1 siRNA
  • 1 ASO
  • 1 bispecific
  • 1 antibody fragment

For large molecules drugs, there were:

  • 6 in oncology or hematology
  • 5 for genetic conditions
  • 2 in neurology
  • 1 in immunology
  • 1 in dermatology
  • 1 in pulmonology

An interesting example is avalglucosidase alfa-ngpt (Nexviazyme), Sanofi Genzyme’s second generation GAA replacement therapy:

Nexviazyme | M6PR 2021 large molecule drug approvals drug hunter recombinant human alpha-glucosidase

The molecule’s glycosylation state was found to be key to its stability in blood and for muscle cell uptake. The molecule was engineered to bear more mannose 6-phosphates compared to Lumizyme, resulting in better uptake and glycogen clearance.

Our complete, hi-res poster with all 16 of the large molecule drugs with modality, drug targets and mechanisms of action, doses and routes of administration, and sponsor appears below for premium members.

You can find remastered examples of our 2020 Large Molecule Approvals Compilation and 2019 Large Molecule Approvals Poster online.

2021 Large Molecule New Drug Approvals
Nexviazyme | M6PR
Saphnelo | IFNAR subunit 1
Aduhelm | Amyloid beta
Rylaze | Asparagine
Zylonta | CD19
Tezspire |TSLP
Skytrofa | GHR 
Amondys 45 | Dys-RNA ex45
Evkeeza | ANGPTL3
Tivdak | TF
Jemperli | PD1 
Besremi | IFNAR 
Skyrrofa |GHR
Amondys 45 | Dys-RNA ex45
Leqvio | PCSK9 mRNA
Evkeeza | ANGPTL3
Tivdak | TF
Jemperli | PD1 
Besremi | IFNAR
Rybrevant } EGRex20 + MET
Adbry | IL-13 
Vyvgart | FcRn

List of 2021 Novel Large Molecule Drug Approvals (excluding Vaccines and Biosimilars)

Nexviazyme | M6PR
Saphnelo | IFNAR subunit 1
Aduhelm | Amyloid beta
Rylaze | Asparagine
Zylonta | CD19
Tezspire |TSLP
Skytrofa | GHR
Amondys 45 | Dys-RNA ex45
Evkeeza | ANGPTL3
Tivdak | TF
Jemperli | PD1
Besremi | IFNAR
Skyrrofa |GHR
Amondys 45 | Dys-RNA ex45
Leqvio | PCSK9 mRNA
Evkeeza | ANGPTL3

You can find our deep dive of all 16 molecules with more details on how they work, their molecular mechanisms of action, how they were discovered, how they’re different from previous treatments, and more here.

Found this helpful? Explore drughunter.com for more drug discovery resources that help you save time, stay up-to-date, and discover ideas.

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