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.  - Deucravacitinib (BMS-986165), the first novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor for the treatment of multiple immune diseases including plaque psoriasis.  - 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.  - 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.  - 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.  - Relatlimab (BMS-986016) is a mAb designed for the treatment of melanoma.  - Betibeglogene autotemcel (Zynteglo), gene therapy for the treatment of beta-thalassemia.  A big year for Alzheimer's disease. A big year for  and 

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Topics: Novel Therapeutics   

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