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The table below is a review of notable updates that occurred in February 2022 for investigational products in development (not an inclusive list). Click on the article title to view our full coverage.
Drug |
Pharmacologic Class |
Article |
Status |
| Cardiovascular Disease | |||
| Asundexian (BAY2433334; Bayer) | Oral Factor XIa inhibitor | Novel Antithrombotic Fast Tracked for Noncardioembolic Ischemic Stroke | Fast Track designation |
| Omecamtiv mecarbil (Cytokinetics, Inc.) | Selective, small molecule cardiac myosin activator | Omecamtiv Mecarbil Under Review for Heart Failure With Reduced Ejection Fraction | NDA accepted for review |
| Endocrine Disorders | |||
| Teplizumab (Provention Bio) | Anti-CD3 monoclonal antibody | Provention Bio Resubmits BLA for Teplizumab to Delay Type 1 Diabetes | BLA resubmitted |
| Gastrohepatic Disorders | |||
| AXA1125 (Axcella Therapeutics) | Oral active mixture of amino acids | Orally Active Amino Acid Mixture Fast Tracked for NASH With Liver Fibrosis | Fast Track designation |
| Hematological Disorders | |||
| Tamibarotene (Syros Pharmaceuticals) | Oral, first-in-class, selective retinoic acid receptor alpha (RARα) agonist | Tamibarotene Gets Orphan Drug Status for Myelodysplastic Syndrome | Orphan Drug designation |
| Immune Disorders | |||
| Baricitinib (Lilly) | JAK inhibitor | Lilly Ends Baricitinib Lupus Program, Provides Update on Atopic Dermatitis sNDA | Phase 3 clinical program for lupus discontinued |
| Infectious Diseases | |||
| Evusheld (tixagevimab co-packaged with cilgavimab; AstraZeneca) | Monoclonal antibody | FDA Authorizes Higher Dose of Evusheld for Preexposure Prophylaxis of COVID-19 | Emergency Use Authorization revised |
| MVA-BN RSV (Bavarian Nordic) | Vaccine | FDA Grants Breakthrough Status to RSV Vaccine Candidate for Older Adults | Breakthrough Therapy designation |
| Sabizabulin (Veru Inc.) | Oral cytoskeleton disruptor | FDA Fast Tracks Sabizabulin for COVID-19 Patients at High Risk for ARDS | Fast Track designation |
| Metabolic Disorders | |||
| HMI-102 (Homology Medicines) | Gene-editing candidate | FDA Places Clinical Hold on Investigational Gene Therapy for Phenylketonuria | Clinical hold |
| Musculoskeletal Disorders | |||
| Abrilada (adalimumab-afzb; Pfizer) | Tumor necrosis factor (TNF) blocker | FDA to Review Abrilada for Interchangeability With Humira | Prior Approval Supplement accepted for review for interchangeable biosimilar |
| Oncology | |||
| Adagrasib (Mirati Therapeutics, Inc.) | Small molecule inhibitor of KRASG12C | Adagrasib Under Review for Previously Treated KRAS G12C-Mutated NSCLC | NDA accepted for review |
| Poziotinib (Spectrum Pharmaceuticals) | Tyrosine kinase inhibitor | Poziotinib Under Review for Previously Treated HER2 Exon 20 Insertion Mutation Positive NSCLC | NDA accepted for review |
| Psychiatric Disorders | |||
| Pimavanserin (Acadia Pharmaceuticals) | Atypical antipsychotic | Pimavanserin sNDA Resubmitted for Alzheimer Disease Psychosis | sNDA resubmitted |
| Respiratory Disorders | |||
| BI 1015550 (Boehringer Ingelheim) | Oral PDE4B inhibitor | Oral PDE4B Inhibitor Gets Breakthrough Tx Status for Idiopathic Pulmonary Fibrosis | Breakthrough Therapy designation |
| Urological Disorders | |||
| Bardoxolone (Reata Pharmaceuticals) | Activator of nuclear factor erythroid-related factor 2 | More Data Needed to Make Decision on Bardoxolone in Alport Syndrome | FDA issued Complete Response Letter |
| Terlipressin (Mallinckrodt) | Vasopressin analogue selective for V1 receptors | Terlipressin Decision Delayed Due to Manufacturing Facility Change | FDA issued Complete Response Letter |
