Drug discovery and NCEs

In 2017 FDA has approved 34 new drugs which are presently in the market. Each year, CDER approves series of new drugs and biological products. Some of these products are often innovative new products that never before have been used in clinical practice. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act. According to Medscape the ratio of researched drugs to eventually approved therapies at between 5,000-to-1 and 10,000-to-1. Nonetheless, if a drug manages to gain FDA approval, the cumulative direct and indirect expenses are huge.  As per estimated study performed by a well-known university,  the true cost to bring a drug to market was US$2.56 billion. This figure is inclusive of just shy of $1.4 billion in average out-of-pocket costs to the drug developer, as well as $1.16 billion in time costs, which are essentially the expected returns that investors forgo while a drug is in development.

Latest FDA approvals include:

Drug Name

Active Ingredient

FDA-approved use for

Aliqopa

copanlisib

To treat adults with relapsed follicular lymphoma

Alunbrig

brigatinib

To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib

Austedo

deutetrabenazine 

For the treatment of chorea associated with Huntington’s disease 

Bavencio

avelumab

To treat metastatic Merkel cell carcinoma

Baxdela

delafloxacin

To treat patients with acute bacterial skin infections

benznidazole

benznidazole

To treat children ages 2 to 12 years old with Chagas disease

Besponsa

inotuzumab ozogamicin

To treat adults with relapsed or refractory acute lymphoblastic leukemia

Bevyxxa

betrixaban

For the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness

Brineura

cerliponase alfa

To treat a specific form of Batten disease

Dupixent

dupilumab

To treat adults with moderate-to-severe eczema (atopic dermatitis)

Emflaza

deflazacort

To treat patients age 5 years and older with Duchenne muscular dystrophy (DMD)

Idhifa

enasidenib

To treat relapsed or refractory acute myeloid leukemia

Imfinzi

durvalumab

To treat patients with locally advanced or metastatic urothelial carcinoma

Ingrezza

valbenazine

To treat adults with tardive dyskinesia 

Kevzara

sarilumab

To treat adult rheumatoid arthritis

Kisqali

ribociclib

To treat postmenopausal women with a type of advanced breast cancer

Mavyret

glecaprevir and pibrentasvir

To treat adults with chronic hepatitis C virus 

Nerlynx

neratinib maleate

To reduce the risk of breast cancer returning

Ocrevus

ocrelizumab

To treat patients with relapsing and primary progressive forms of multiple sclerosis

Parsabiv

etelcalcetide

To treat secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis

Radicava

edaravone

To treat patients with amyotrophic lateral sclerosis (ALS)

Rydapt

midostaurin

To treat acute myeloid leukemia

Siliq

brodalumab

To treat adults with moderate-to-severe plaque psoriasis

Solosec

secnidazole

To treat bacterial vaginosis

Symproic

naldemedine

For the treatment of opioid-induced constipation

Tremfya

guselkumab

For the treatment of adult patients with moderate-to-severe plaque psoriasis

Trulance

plecanatide

To treat Chronic Idiopathic Constipation (CIC) in adult patients.

Tymlos

abaloparatide

To treat osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies

Vabomere

meropenem and vaborbactam

To treat adults with complicated urinary tract infections 

Verzenio

abemaciclib

To treat certain advanced or metastatic breast cancers

Vosevi

sofosbuvir, velpatasvir and voxilaprevir

To treat adults with chronic hepatitis C virus

Xadago

safinamide

To treat Parkinson’s disease

Xermelo

telotristat ethyl

To treat carcinoid syndrome diarrhea

Zejula

niraparib

For the maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers

 

 

  • Computer Aided Drug Design (CADD)
  • Insilco Drug Discovery
  • Novel Detection Technologies and Drug Discovery
  • New Chemical Entity Exclusivity Determinations
  • Statutory and regulatory framework
  • NME versus NCE

Related Conference of Drug discovery and NCEs

June 08-09, 2018

7th International conference on Pharmaceutical Auditing

Baltimore, Maryland, USA
June 27-28, 2018

4th International Conference on Drug Discovery, Designing and Development

Vancouver, British Columbia, Canada
August 20-21, 2018

9th Asian Biologics and Biosimilars Congress

Tokyo, Japan
October 18-19, 2018

18th World Pharma Congress

Warsaw, Poland
August 15-17, 2018

8th World Congress Spectroscopy and Analytical Techniques

Stockholm, Sweden
September 18-19, 2018

6th European Biopharma Congress

Amsterdam, Netherlands

Drug discovery and NCEs Conference Speakers

Recommended Sessions

Related Journals

Are you interested in