The table below is a review of notable updates that occurred in May 2022 for investigational products in development (not an inclusive list).

 

Drug Pharmacologic Class Proposed Indication Status
Cardiovascular Disease
Furoscix® (furosemide; scPharmaceuticals Inc.) pH-neutral formulation of furosemide delivered via wearable, pre-programmed on-body drug delivery system Treatment of congestion due to fluid overload in adults with NYHA Class II and Class III chronic heart failure who display reduced responsiveness to oral diuretics and who do not require hospitalization. NDA accepted for filing
Dermatological Disorders
Bimekizumab (UCB) Humanized monoclonal lgG1 antibody that inhibits IL-17A and IL-17F Treatment of adults with moderate to severe plaque psoriasis. Complete Response Letter issued
Dupilumab (Regeneron Pharmaceuticals, Inc.) Interleukin-4 receptor alpha antagonist Treatment of adults with prurigo nodularis. Priority Review granted
Gastrohepatic Disorders
Ervogastat/clesacostat (Pfizer Inc.)
Diaclyglycerol O-acyltransferase 2 inhibitor and acetyl-CoA carboxylase inhibitor Treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis. Fast Track designation
Vonoprazan (Phathom Pharmaceuticals)
Oral small molecule potassium-competitive acid blocker Treatment for the healing of all grades of erosive esophagitis and relief of heartburn, and maintenance of healing of all grades of erosive esophagitis and relief of heartburn. NDA accepted for review
Hematological Disorders
Etranacogene dezaparvovec (CSL Behring)
AAV gene therapy Treatment of adults with hemophilia B. Priority Review granted
GPH101 (Graphite Bio, Inc.)
Gene-edited autologous hematopoietic stem cell therapy (HSCT) Treatment of sickle cell disease. Fast Track designation
Immunization
BLB-201 (Blue Lake Biotechnology) Respiratory syncytial virus (RSV) vaccine Prevention of RSV associated disease in adults aged over 60 and children aged under 2 years. Fast Track designation
Infectious Diseases
Fluvoxamine maleate (various generic manufacturers)
SSRI Outpatient treatment of COVID-19 in adults to prevent progression to severe disease and/or hospitalization. EUA request declined
Kidney Disease
Sparsentan (Travere Therapeutics, Inc.)
Dual endothelin angiotensin receptor antagonist Treatment of immunoglobulin A (lgA) nephropathy. Priority Review granted
Neurologic Disorders
ABBV-951 (foscarbidopa/foslevodopa; AbbVie)
Dopa-decarboxylase inhibitor + dopamine precursor Treatment of motor fluctuations in patients with advanced Parkinson disease. NDA submitted
Omaveloxolone (Reata Pharmaceuticals)
Nrf2 activator Treatment of Friedreich ataxia. Priority Review granted
UB-311 (Vaxxinity) Immunotherapeutic vaccine candidate that targets toxic forms of aggregated amyloid beta in the brain Treatment of Alzheimer disease. Fast Track designation
Ob/Gyn
Myfembree (relugolix, estradiol, and norethindrone acetate; Myovant Sciences) GnRH antagonist + estrogen + progestin Management of moderate to severe pain associated with endometriosis. PDUFA target action date has been extended
Oncology
Imfinzi (durvalumab; AstraZeneca) PD-L1 blocking antibody In combination with standard of care chemotherapy for treatment of patients with locally advanced or metastatic biliary tract cancer. Priority Review designation
Mirvetuximab soravtansine (ImmunoGen) Antibody-drug conjugate comprised of a FRα-binding antibody and a tubulin-targeting agent (maytansinoid payload DM4) Treatment of patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments. Priority Review granted
Nubeqa (darolutamide; Bayer) Androgen receptor inhibitor In combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer. Priority Review granted
Tasquinimod (Active Biotech AB) Small molecule immune modulator Treatment of myelofibrosis. Orphan Drug designation
Pain Management
AXS-07 (meloxicam/rizatriptan; Axsome Therapeutics) NSAID (COX-2 inhibitor) + selective 5-HT1B/1D receptor agonist Acute treatment of migraine. Complete Response Letter issued
Zavegepant (Biohaven) Calcitonin gene-related peptide (CGRP) receptor antagonist Acute treatment of migraine. NDA accepted for review
Respiratory Disorders
PT027 (albuterol/budesonide; Avillion LLP)  Short-acting beta2-agonist + inhaled corticosteroid As-needed treatment or prevention of bronchoconstriction and for the prevention of exacerbations in patients with asthma 4 years of age and older. NDA accepted for filing
TT-101 (Tvardi Therapeutics)  Small molecule STAT3 (signal transducer and activator of transcription 3) inhibitor Treatment of idiopathic pulmonary fibrosis. Orphan Drug designation