It has been quite a while since our last update, so this is a big one! As a reminder, this is a continuation of our new blog series to update you on recent FDA drug approvals, new indications, and other changes. You can find the recap or notable FDA drug changes (AdCom, PDUFDA, etc.) for January – June 2020 below. If we are missing information or you’d like more information about one of the noted changes, feel free to contact us.
| Date | Name | Company | Indication |
|---|---|---|---|
| Date | Product | Company | Indication |
| 1/6/2020 | Fiasp | Novo Nordisk | to improve glycemic control in adult and pediatric patients with diabetes mellitus |
| 1/8/2020 | Keytruda | Merck | treatment of patients with bacillus Calmette-Guérin (BCG)–unresponsive, high-risk, non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) |
| 1/9/2020 | Mycamine | Astellas | treatment of candidemia, candidiasis, Candida peritonitis, and abscesses without meningoencephalitis and/or ocular dissemination in adults and children 4 months of age and older |
| 1/9/2020 | Ayvakit | Blueprint Medicines Corp | treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations |
| 1/13/2020 | Valtoco | Neurelis |
cute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in people with epilepsy 6 years of age and older |
| 1/13/2020 | Numbrino | Lannett Company, Inc | Local nasal analgesia / anesthetic |
| 1/17/2020 | Ozempic | Novo Nordisk | to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease |
| 1/22/2020 | Tepezza | Horizon Therapeutics | treatment of adults with thyroid eye disease |
| 1/22/2020 | Micra AV | Medtronic | Leadless AV synchronous pacemaker |
| 1/24/2020 | Tazverik | Epizyme | treatment of epithelioid sarcoma |
| 1/27/2020 | Dificid | Merck | treatment of Clostridioides difficile-associated diarrhea (CDAD) in children aged 6 months and older |
| 1/28/2020 | Trijardy XR | Boehringer Ingelheim / Eli Lilly | to improve glycemic control in adults with type 2 diabetes mellitus |
| 1/28/2020 | Ajovy | Teva | New auto-injector approved for prevention of migraine |
| 1/29/2020 | Monoferric | Pharmacosmos Therapeutics |
treatment of iron deficiency anemia (IDA) in adult patients who have an intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-hemodialysis dependent chronic kidney disease |
| 1/31/2020 | Palforzia | Aimmune Therapeutics | mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut in patients aged 4-17 |
| 2/6/2020 | Audenz | Seqirus | to help protect individuals six months of age and older against influenza A (H5N1) |
| 2/10/2020 | Pemfexy | Eagle Pharmaceuticals | ocally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin; locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as maintenance treatment; locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy as a single agent; and malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery in combination with cisplatin |
| 2/13/2020 | Pizensy | Braintree | treatment of chronic idiopathic constipation in adults |
| 2/14/2020 | Twirla | Agile Therapeutics | method of contraception for use in women of reproductive potential with a BMI < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate |
| 2/17/2020 | Voltaren Arthritis Pain | GlaxoSmithKline | for the temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle or knee in adults (18 years and older) |
| 2/17/2020 | Pataday Twice Daily Relief | Alcon | temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair or dander |
| 2/17/2020 | Pataday Once Daily Relief | Alcon | temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander, for nonprescription use |
| 2/21/2020 | Anjeso | Baudax Bio |
treatment of moderate to severe pain in adults, either by itself of with other nonsteroidal anti-inflammatory drug (NSAID) analgesics |
| 2/21/2020 | Nexletol | Esperion |
to lower LDL cholesterol in patients with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| 2/21/2020 | Vyepti | Lundbeck | preventive treatment of migraine in adults |
| 2/24/2020 | Trulicity | Eli Lilly | to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors |
| 2/24/2020 | Fluad Quadrivalent | Seqirus | to protect adults aged 65 years or older against seasonal influenza |
| 2/26/2020 | Nexlizet | Esperion | for use on top of maximally tolerated statins in adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who haven’t met their low-density lipoprotein cholesterol (LDL-C) targets |
| 2/27/2020 | Barhemsys | Acacia Pharma | for the prevention and treatment of post operative nausea and vomiting in adult patients |
| 2/27/2020 | Nurtec ODT | Biohaven Pharmaceutical | acute treatment of migraine in adults |
| 3/2/2020 | Sarclisa | Sanofi-Genzyme |
treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor |
| 3/2/2020 | Generic Daraprim | Cerovene | treatment of toxoplasmosis when used with a sulfonamide |
| 3/2/2020 | Pizensy | Sebela | Treatment of Chronic Idiopathic Constipation in Adults |
| 3/5/2020 | Durysta | Allergan | to Lower Intraocular Pressure In Open-Angle Glaucoma or Ocular Hypertension Patients |
| 3/6/2020 | Isturisa | Recordati/Novartis |
for adults with Cushing’s disease who either can’t have pituitary gland surgery or who have had the surgery but still have the disease |
| 3/9/2020 | Ofev | Boehringer Ingelheim | Treatment of Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype |
| 3/11/2020 | Opdivo/Yervoy | Bristol Myers Squibb | treatment of (HCC) in patients who have previously been treated with sorafenib |
| 3/20/2020 | Epclusa | Gilead | for Children Ages 6 and Older or Weighing at Least 17 kg with Chronic Hepatitis C Infection |
| 3/24/2020 | Eucrisa | Pfizer | Children as Young as 3 Months of Age With Mild-to-Moderate Atopic Dermatitis |
| 3/26/2020 | Zeposia | Bristol Myers Squibb |
treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease |
| 3/27/2020 | Triferic AVNU | Rockwell Medical | for Replacement of Iron and Maintenance of Hemoglobin in Hemodialysis Patients |
| 3/30/2020 | Imfinzi | AstraZeneca | in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) |
| 3/30/2020 | Taltz | Eli Lilly | treatment of pediatric patients (ages 6 to under 18) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy |
| 4/1/2020 | Sevenfact | Laboratoire Francais du Fractionnement et des Biotechnologies |
treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors |
| 4/3/2020 | Reblozyl | Bristol Myers Squibb | to treat patients with myelodysplastic syndromes (MDS) who require red blood cell transfusions and have failed an erythropoiesis stimulating agent |
| 4/13/2020 | Koselugo | AstraZeneca |
treatment of pediatric patients aged 2 years and older with type 1 neurofibromatosis (NF1) with symptomatic, inoperable plexiform neurofibromas |
| 4/15/2020 | Jelmyto | UroGen Pharma | Treatment of Low-Grade Upper Tract Urothelial Cancer |
| 4/17/2020 | Tukysa | Seattle Genetics | treatment of advanced HER2-positive breast cancer |
| 4/17/2020 | Pemazyre | Incyte | treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement |
| 4/21/2020 | Emerphed | Nexus Pharmaceuticals | Ready-to-Use Injection for Hypotension During Anesthesia |
| 4/21/2020 | Imbruvica | AbbVie | in combination with rituximab for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) |
| 4/22/2020 | Trodelvy | Immunomedics | treatment of metastatic triple-negative breast cancer (TNBC) |
| 4/24/2020 | MenQuadfi | Sanofi | prevention of invasive meningococcal disease in persons 2 years of age and older |
| 4/27/2020 | Ongentys | Neurocrine Biosciences, | add-on treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes |
| 4/29/2020 | Zejula | GlaxoSmithKline | maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy |
| 5/1/2020 | Darzalex Faspro | Janssen | Treatment of patients with multiple myeloma |
| 5/2/2020 | Remdesivir | Gilead | treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease |
| 5/4/2020 | Fensolvi | Tolmar Pharmaceuticals | treatment of pediatric patients two years of age and older with central precocious puberty (CPP) |
| 5/5/2020 | Farxiga | AstraZeneca | to reduce the risk of cardiovascular death or hospitalization in heart failure patients with a reduced ejection fraction (HFrEF) and with or without Type 2 diabetes |
| 5/6/2020 | Tabrecta | Novartis |
adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test |
| 5/6/2020 | Elyxyb | Dr. Reddy’s | acute treatment of migraine with or without aura in adults |
| 5/8/2020 | Retevmo | Loxo / Eli Lilly |
Advanced medullary thyroid cancer (MTC) or MTC that has spread, in patients 12 and older who require systemic therapy (a treatment option that spreads across the entire body, is not targeted) – AND – Advanced RET fusion-positive thyroid cancer in those age 12 and older that requires systemic therapy that has stopped responding to radioactive iodine therapy or is not appropriate for radioactive iodine therapy – AND – Non-small cell lung cancer (NSCLC) that has spread in adults. |
| 5/8/2020 | Lynparza | AstraZeneca | As first-line maintenance treatment of HRD-positive* advanced ovarian cancer, defined by either a deleterious or suspected deleterious BRCA mutation and/or genomic instability, following complete or partial response to first-line platinum-based chemotherapy |
| 5/15/2020 | Pomalyst | Bristol Myers Squibb | treatment of AIDS-related Kaposi sarcoma that is resistant to highly active antiretroviral therapy (HAART) or that occurs in HIV-negative patients |
| 5/15/2020 | Rubraca | Clovis | use in patients with metastatic castration-resistant prostate cancer (mCRPC) that harbors deleterious BRCA mutations (germline and/or somatic) |
| 5/15/2020 | Opdivo/Yervoy | Bristol Myers Squibb | first-line treatment for patients with metastatic non-small-cell lung cancer (NSCLC) whose tumors express PD-L1 (≥ 1%) |
| 5/18/2020 | Qinlock | Deciphera Pharmaceuticals | treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib |
| 5/20/2020 | Tecentriq | Genentech | initial treatment for adults with metastatic NSCLC whose tumours have high PD-L1 expression, without EGFR or ALK mutations |
| 5/20/2020 | Lynparza | AstraZeneca | patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) |
| 5/21/2020 | Ferripox | Chiesi |
treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate |
| 5/21/2020 | Kynmobi | Sunovion | for the acute, intermittent treatment of ‘off’ episodes in patients with Parkinson’s disease (PD) |
| 5/22/2020 | Alunbrig | Takeda | for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test |
| 5/26/2020 | Phexxi | Evofem Biosciences | to prevent pregnancy in women of reproductive potential |
| 5/27/2020 | Sirturo | Janssen | as part of combination therapy in adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multi-drug resistant tuberculosis (MDR-TB) |
| 5/27/2020 | IV artesunate | Amivas | to treat adults and children with severe malaria |
| 5/27/2020 | Dupixent | Sanofi/Regeneron | for children aged 6-11 years with moderate to severe atopic dermatitis |
| 5/27/2020 | VESIcare LS | Astellas | treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 2 years and older |
| 5/27/2020 | Cerianna | Siemens Healthineers / Zionexa | PET Imaging Agent for Use in Patients with Recurrent or Metastatic Breast Cancer |
| 5/28/2020 | Tauvid | Avid Radiopharmaceuticals / Eli Lilly |
positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) |
| 5/29/2020 | Cyramza | Eli Lilly | First-Line Treatment for Metastatic EGFR-Mutated Non-Small Cell Lung Cancer |
| 6/1/2020 | Oriahnn | AbbVie / Neurocrine Biosciences | Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-menopausal Women |
| 6/1/2020 | Brilinta | AstraZeneca | with aspirin to cut the risk for a first myocardial infarction (MI) or stroke in high-risk patients with coronary artery disease (CAD) but no history of MI or stroke |
| 6/1/2020 | Zilxi | Menlo Therapeutics | treatment of inflammatory lesions of rosacea in adults |
| 6/1/2020 | Tecentriq | Genentech | treatment of people with unresectable or metastatic hepatocellular carcinoma or HCC, who have not received prior systemic therapy |
| 6/1/2020 | Taltz | Eli Lilly | treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation |
| 6/9/2020 | Recarbrio | Merck |
to treat adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) |
| 6/10/2020 | Opdivo | Bristol Myers Squibb | Treatment of Patients with Advanced Esophageal Squamous Cell Carcinoma (ESCC) After Prior Fluoropyrimidine- and Platinum-based Chemotherapy |
| 6/11/2020 | Uplinza | Viela Bio | Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) |
| 6/11/2020 | Semglee | Mylan / Biocon | to control high blood sugar in adults with type 2 diabetes and adult and pediatric patients with type 1 diabetes |
| 6/12/2020 | Gardasil 9 | Merck | prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58 |
| 6/12/2020 | Tivicay PD | ViiV |
reatment of human immunodeficiency virus type 1 (HIV-1) infection in paediatric patients (treatment-naïve or -experienced but INSTI- naïve) aged at least four weeks and weighing at least 3kg, as well as an extended indication to expand the use of the already approved Tivicay (dolutegravir) 50mg film-coated tablet in paediatric HIV patients weighing 20kg and above |
| 6/15/2020 | Zepzelca | PharmaMar / Jazz Pharmaceuticals |
treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression, after platinum-based chemotherapy |
| 6/16/2020 | EndeavorRx device | Akili Interactive | for the improvement of attention function, as assessed by computer-based testing |
| 6/17/2020 | Keytruda | Merck | monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options |
| 6/18/2020 | Cosentyx | Novartis | treatment of active nonradiographic axial spondyloarthritis (nr-axSpA) |
| 6/18/2020 | Lyumjev | Eli Lilly | treatment of adults with type 1 and type 2 diabetes |
| 6/18/2020 | Crysvita | Ultragenyx Pharmaceutical / Kyowa Kirin |
treatment of fibroblast growth factor 23 (FGF23)-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adults and pediatric patients 2 years of age and older |
| 6/19/2020 | Tazverik | Epizyme | treatment of relapsed or refractory (R/R) follicular lymphoma in adult patients with tumors harboring an EZH2 mutation |
| 6/19/2020 | Ilaris | Novartis | include all patients with active Still’s disease older than 2 years, adding adult-onset Still’s disease (AOSD) to a previous approval for juvenile-onset Still’s disease, also known as systemic juvenile idiopathic arthritis (sJIA) |
| 6/19/2020 | Gimoti | Evoke Pharma | for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis |
| 6/22/2020 | ReActiv8 | Mainstay Medical |
to treat intractable chronic low back pain associated with multifidus muscle dysfunction found on imaging or physiologic testing in adults who have failed other therapies and are not candidates for spine surgery |
| 6/22/2020 | Xpovio | Karyopharm |
treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy |
| 6/24/2020 | Keytruda | Merck | recurrent or metastatic cutaneous squamous cell carcinoma that can’t be cured by surgery or radiation |
| 6/26/2020 | Fintepla | Zogenix | treatment of seizures associated with Dravet syndrome in children age 2 years and older |
| 6/26/2020 | Mycapssa | Chiasma |
long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide |
| 6/29/2020 | Phesgo | Genentech | injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer |
| 6/29/2020 | Keytruda | Merck | in previously untreated patients with metastatic or inoperable colorectal cancer and one of two biomarkers—microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors |
| 6/30/2020 | Dojolvi | Ultragenyx Pharmaceutical |
a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD) |
Stay tuned, as we will continue to update this FDA new drug approval series regularly. We hope you enjoy your 4th of July, and look for our next post in this series to publish in early October!
