Friday, January 11, 2019

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)

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA

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