59 new drugs approved by US FDA in 2018

Last year, the US FDA approved a record 59 new drugs, which included 19 first-in-class agents, 34 novel drugs for rare diseases, and a record seven biosimilars.

In 2017, 46 new drugs had been approved; in 2016, 22 drugs received the FDA green signal and in between 2009 and 2017, on an average 33 new drugs were accorded FDA approval.

Here is a list of the drugs approved by the FDA in 2018.


Ultomiris ravulizumab To treat paroxysmal nocturnal hemoglobinuria (PNH)
Elzonris tagraxofusp-erzs To treat blastic plasmacytoid dendritic cell neoplasm (BPDCN)
Asparlas calaspargase pegol-mknl To treat acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years
Motegrity prucalopride To treat chronic idiopathic constipation
Xospata gilteritinib To treat patients who have relapsed or refractory acute myeloid leukemia (AML)
Firdapse amifampridine To treat  Lambert-Eaton myasthenic syndrome in adults
Vitrakvi larotrectinib To treat patients whose cancers have a specific genetic feature (biomarker)
Daurismo glasdegib To treat newly-diagnosed AML in adult patients
Gamifant emapalumab-lzsg To treat primary hemophagocytic lymphohistiocytosis
Aemcolo rifamycin To treat travelers’ diarrhea
Yupelri revefenacin To treat patients with chronic obstructive pulmonary disease (COPD)
Lorbrena lorlatinib To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer
Xofluza baloxavir marboxil For the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours
Talzenna talazoparib For the treatment of locally advanced or metastatic breast cancer patients with a germline BRCA mutation
Tegsedi inotersen To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
Revcovi elapegademase-lvlr To treat Adenosine Deaminase-Severe Combined Immuno-deficiency (ADA-SCID)
Nuzyra omadacycline To treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections
Seysara sarecycline To treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients ≥9 years
Libtayo cemiplimab-rwlc To treat cutaneous squamous cell carcinoma
Vizimpro dacomitinib To treat metastatic non-small-cell lung cancer
Emgality galcanezumab-gnlm For the preventive treatment of migraine in adults
Copiktra duvelisib To treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma
Ajovy fremanezumab-vfrm For the preventive treatment of migraine in adults
Lumoxiti moxetumomab pasudotox-tdfk To treat hairy cell leukemia
Pifeltro doravirine To treat HIV-1 infection in adult patients
Xerava eravacycline To treat complicated intra-abdominal infections in patients ≥ 18 years
Takhzyro lanadelumab To treat types I and II hereditary angioedema
Oxervate cenegermin-bkbj To treat neurotrophic keratitis
Diacomit stiripentol To treat seizures associated with Dravet syndrome in patients ≥2 years taking clobazam
Galafold migalastat To treat adults with Fabry disease
Annovera segesterone acetate and ethinyl estradiol vaginal system New vaginal ring used to prevent pregnancy for an entire year
Onpattro patisiran To treat the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adult patients
Poteligeo mogamulizumab-kpkc To treat two rare types of non-Hodgkin lymphoma
Mulpleta lusutrombopag To treat thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure
Omegaven fish oil triglycerides As a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis
Orilissa elagolix sodium For the management of moderate to severe pain associated with endometriosis
Krintafel tafenoquine For the radical cure (prevention of relapse) of Plasmodium vivax malaria
Tibsovo ivosidenib To treat patients with relapsed or refractory acute myeloid leukemia
TPOXX tecovirimat To treat smallpox
Braftovi encorafenib To treat unresectable or metastatic melanoma
Mektovi binimetinib To treat unresectable or metastatic melanoma
Zemdri plazomicin To treat adults with complicated urinary tract infections
Epidiolex cannabidiol To treat rare, severe forms of epilepsy
Moxidectin moxidectin To treat onchocerciasis due to Onchocerca volvulus in patients aged ≥12 years
Olumiant baricitinib To treat moderately to severely active rheumatoid arthritis
Palynziq pegvaliase-pqpz To treat adults with a rare and serious genetic disease known as phenylketonuria
Doptelet avatrombopag To treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure
Lokelma sodium zirconium cyclosilicate To treat hyperkalemia
Aimovig erenumab-aooe For the preventive treatment for migraine
Lucemyra lofexidine hydrochloride For the non-opioid treatment for management of opioid withdrawal symptoms in adults
Akynzeo fosnetupitant and palonosetron To prevent acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy
Crysvita burosumab-twza To treat adults and children aged ≥ 1 year with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets
Tavalisse fostamatinib To treat thrombocytopenia in adult patients with persistent or chronic immune thrombocytopenia (ITP)
Ilumya tildrakizumab To treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy
Trogarzo ibalizumab-uiyk To treat HIV patients who have limited treatment options
Erleada apalutamide To treat a certain type of prostate cancer using novel clinical trial endpoint
Symdeko tezacaftor; ivacaftor To treat cystic fibrosis in patients aged ≥ 12 years
Biktarvy bictegravir, embitcitabine, tenofovir alafenamide To treat infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen
Lutathera lutetium Lu 177 dotatate To treat a type of cancer that affects the pancreas or gastrointestinal tract “gastro-enteropancreatic neuroendocrine tumors” (GEP-NETs)


Seven new Biosimilars approved

  • Fulphila(pegfilgrastim-jmdb) and Udenyca (pegfilgrastim-cbqv), respectively the first and second biosimilars to Neulasta
  • Herzuma(trastuzumab-abtr), the second biosimilar to Herceptin
  • Hyrimoz(adalimumab-adaz), the third biosimilar to Humira
  • Nivestym(filgrastim-aafi), the second biosimilar to Neupogen
  • Retacrit(epoetin alfa-epbx), the first biosimilar to Epogen/Procrit
  • Truxima(rituximab-abbs), the first biosimilar to Rituxan

(Source: US FDA, Medscape)

Be the first to comment

Leave a Reply

Your email address will not be published.