Anticipated Drug Approvals 2022

by Chris De Savi    Contributor        Biopharma insight

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Topics: Novel Therapeutics   
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Drug Discovery crystal ball gazing for the year ahead. And the hottest prospects are discussed below.

We already have 5 CDER (FDA) approvals this year which are tantalizing new treatments for patients -

  1. Daridorexant (Quviviq), a selective dual antagonist of the orexin receptors OX1 and OX2 used for the treatment of insomnia. Idorsia Pharmaceuticals Ltd
  2. Abrocitinib (Cibinqo), a new JAK1 kinase inhibitor used for the treatment of atopic dermatitis. Pfizer
  3. Tebentafusp (Kimmtrak), a bispecific gp100 peptide-HLA-directed CD3 T cell engager used to treat uveal melanoma (eye cancer). Immunocore
  4. Faricimab (Vabysmo), a bispecific mAb, a VEGF, and Ang-2 inhibitor used for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Genentech
  5. Sutimlimab (Enjaymo), a mAb that is used to treat adults with cold agglutinin disease (CAD). Sanofi


But what are the hottest and 'potentially' most lucrative drug approvals on the horizon this year?

- Adagrasib (MRTX-849), a KRASG12C inhibitor for the treatment of various cancers. Mirati Therapeutics

- Deucravacitinib (BMS-986165), the first novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor for the treatment of multiple immune diseases including plaque psoriasis. Bristol Myers Squibb

- Donanemab (LY3002813), a humanized IgG1 monoclonal antibody targeted against an epitope at the N-terminal of a specific type of amyloid beta (Aβ) for the treatment of Alzheimer's Disease (AD). 

- Tirzepatide, an analogue of the gastric inhibitory polypeptide (GIP), a human hormone that stimulates the release of insulin from the pancreas, for the treatment of Type 2 diabetes. Eli Lilly and Company

- Vutrisiran, an investigational RNAi therapeutic in development for the treatment of transthyretin-mediated (ATTR) amyloidosis, which encompasses both hereditary ATTR (hATTR) amyloidosis and wild-type ATTR (wtATTR) amyloidosis. Alnylam Pharmaceuticals

- Mavacamten, a potential first-in-class, oral, allosteric modulator of cardiac myosin, is under investigation for the treatment of conditions in which excessive cardiac contractility and impaired diastolic filling of the heart are the underlying cause. Bristol Myers Squibb

- Relatlimab (BMS-986016) is a mAb designed for the treatment of melanoma. Bristol Myers Squibb

- Betibeglogene autotemcel (Zynteglo), gene therapy for the treatment of beta-thalassemia. bluebird bio

A big year for Alzheimer's disease. A big year for Eli Lilly and Company and Bristol Myers Squibb

Topics: Novel Therapeutics   

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