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 |
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| 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 |
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| 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 |
