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