QUESTION: List of drugs indicated for both adults and pediatrics among the drugs indicated for CNS?

ANSWER just simple filter and short function is used to seprate the list of drugs for both adult and pediatrics.
Brand name
Abilify
Briviact
Extavia
Fycompa
Gilenya
Inovelon/Banzel
Keppra

Brand Name INN Name Manufacturer Molecule Type MA date (EMA) Orphan Status
(EMA)

Abilify aripiprazole Otsuka PharmaceSmall molecule 6/4/2004 Not orphan

Abilify aripiprazole Otsuka PharmaceSmall molecule 3/31/2008 Not orphan

Briviact brivaracetam UCB Pharma Ltd Small molecule 1/13/2016 Not orphan

Extavia interferon beta-1b Novartis Biologic 5/20/2008 Not orphan

Fycompa perampanel Eisai Ltd Small molecule 7/23/2012 Not orphan

Fycompa perampanel Eisai Ltd Small molecule 6/22/2015 Not orphan

Gilenya fingolimod hydrochloride Novartis Small molecule 3/17/2011 Not orphan

Inovelon/Banzel rufinamide Eisai Ltd Small molecule 1/16/2007 Not orphan

Keppra levetiracetam UCB Pharma Ltd Small molecule 9/29/2000 Not orphan

Keppra levetiracetam UCB Pharma Ltd Small molecule 8/7/2006 Not orphan

Keppra levetiracetam UCB Pharma Ltd Small molecule 1/4/2007 Not orphan
t and pediatrics.

Adult/Paediatric Route of HAS Assessment Sub-Therapy Area

Availability Administration Outcome (ASMR)

Both adults and pediatrics Oral ASMR IV, ASMR III Schizophrenia

Both adults and pediatrics Oral ASMR V Bipolar disorder

Both adults and pediatrics Oral ASMR V Partial-onset seizures

Both adults and pediatrics Subcutaneous ASMR V Multiple sclerosis

Both adults and pediatrics Oral ASMR V Partial-onset seizures

Both adults and pediatrics Oral ASMR V Tonic-clonic seizures

Both adults and pediatrics Oral ASMR IV Multiple sclerosis

Both adults and pediatrics Oral ASMR IV Lennox Gastaut syndrome

Both adults and pediatrics Intravenous, Oral ASMR IV Partial-onset seizures

Both adults and pediatrics Intravenous, Oral ASMR III Myoclonic seizures

Both adults and pediatrics Intravenous, Oral ASMR IV Tonic-clonic seizures

 Drug class Price per year or course
(FR)

Dopamine antagonists,5 572

Dopamine antagonists,5 272

Sodium channel antagon 913

Immunostimulants 8,666

AMPA receptor antagoni 847

AMPA receptor antagoni 847

Sphingosine 1 phosphat 18,625

Sodium channel antagon 1,764

SV2A protein modulator 367

SV2A protein modulator 367

SV2A protein modulator 367

QUESTION: List the products by sub therapy area (products by individual therapy area)

ANSWER: Sub-Therapy Area Brand Name (empty)

pivot table is used. Alzheimers disease
Ebixa
Exelon
Amyotropic lateral sclerosis
Rilutek
Anxiety disorder
Cymbalta
Lyrica
Bipolar disorder
Abilify
Demyelination
Avonex
Depression
Brintellix/Trintellix
Cymbalta
Epilepsy
Buccolam
Insomnia
Slenyto
Lennox Gastaut syndrome
Inovelon/Banzel
Multiple sclerosis
Avonex
Betaferon/Betaseron
Extavia
Fampyra/Ampyra
Gilenya
Ocrevus
Plegridy
Rebif
Tecfidera
Myoclonic seizures
Diacomit
Keppra
Narcolepsy
Wakix
Pain
Cymbalta
Instanyl
Lyrica
PecFent/Lazanda
Prialt
Parkinson’s disease
Azilect
 Comtan
Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz)
Exelon
Neupro
Sifrol
Partial-onset seizures
Briviact
Fycompa
Keppra
Lyrica
Restless-legs syndrome
Neupro
Sifrol
Schizophrenia
Abilify
Abilify Maintena
Trevicta (previously Paliperidone Janssen)
Tonic-clonic seizures
Fycompa
Keppra
Total Result
pone Sandoz)
QUESTION: List the major companies that have products approved in bipolar disorder

ANSWER: Sub-Therapy Area Manufacturer (empty)

pivot table is used. Bipolar disorder
Otsuka Pharmaceutical Ltd
Total Result
QUESTION: Which diseases are considered as orphan?

ANSWER: orphan disease is considered as rare disease as compare to other common disease , according to USFDA if the d
in India disease population is less than 5 lakh for disease to be known as orphan. For example cold is common d
Center for Advancing Translational Science(NIH).
ccording to USFDA if the disease patients is less than one lakh it is orphan disease,
example cold is common disease, but Acromegaly is an orphan disease as per National
QUESTION: How many orphan drugs were approved by EMA in each year between 2015 and 2018?

ANSWER: MA date (EMA) - all -

Pivot table is used.
Count - Orphan Status (EMA) Orphan Status (EMA)
Years Not orphan Orphan Total Result
2015 1 1
2016 1 1 2
2018 2 2
Total Result 4 1 5

orphan drug

2015
2016
2018
Total Result
QUESTION: List the products that currently have a price higher than 10000 euros per year and in what indications among the drugs ind

ANSWER: Price per year or course (FR) - multiple -

Sum - Price per year or course (FR) Brand Name

Drug class Betaferon/Betaseron Gilenya Ocrevus
B-cell inhibitors 21,700
Immunostimulants 10,569
NF E2 related factor 2 stimulants
Sphingosine 1 phosphate receptor modulators 18,625

€ 25,000.00 € 21,700.00
€ 20,000.00 € 18,625.00

€ 15,000.00
€ 10,569.00 € 10,285.00
€ 10,000.00
€ 5,000.00
€ 0.00
rs s s rs Brand Name
to a nt a nt to Betaferon/Betaseron
i bi ul ul ula
h m
l in ti sti
m od Gilenya
el os rm
-c un r2 to Ocrevus
B m cto p
Im f a ce Tecfidera
e d re
at te
re
l
pha
E2 os
ph
NF 1
e
in
g os
n
hi
Sp

THE HIGHEST IS OCREVUS IN B-CELL INHIBITORS , AND LOWEST IS TECFIDERA FOR RESPECTIVE CATEGORY.
cations among the drugs indicated for CNS?

Tecfidera

10,285

PECTIVE CATEGORY.
Average cost of treatment by sub therapy

Sub-Therapy Area Average - Price per year or course (FR)

Alzheimers disease 198 Tota
Amyotropic lateral sclerosis 1,598 12000
Anxiety disorder 109 10000
Bipolar disorder 272 8000
Demyelination 8,008 6000
Depression 323 4000
Epilepsy 69 2000
Insomnia 2,055
0
Lennox Gastaut syndrome 1,764 e r n y e s
re Pai
n
as de ti o ps m
Multiple sclerosis 10,700 si e isor ina pile dro eizu ei
sd d el E syn c s ts
Myoclonic seizures 3,831 er iety m y t ni s e
m
ei Anx De au lo n S
zh a st yoc a l -o
Narcolepsy 4,800 Al G M rti
ox Pa
Pain 1,009 nn
Le
Parkinson’s disease 629
Partial-onset seizures 567
Restless-legs syndrome 309 HIGHEST IS MULTIPLE SCLEROSIS.
Schizophrenia 1,851 LOWEST IS EPILEPCY,ALZHEIMER,ANXIETY.
Tonic-clonic seizures 607
 Total
00
00
00
00
00
Average - Price per year or
00 course (FR)
0
e r n y e s n s a
as de tio ps m re Pai ure eni
si e isor ina pile dro eizu e
zi hr
d d el E syn c s p
ty m y t s zo
xie e ut
l oni nse chi
n D ta oc -o S
G as y ti al
M r
ox Pa
nn
Le

S MULTIPLE SCLEROSIS.
S EPILEPCY,ALZHEIMER,ANXIETY.
How many small molecules and biologics were approved for multiple sclerosis?

Sub-Therapy Area Multiple sclerosis

Molecule Type Count - Molecule Type

Biologic 6
Small molecule 3
Total Result 9

APPROVED MOLECULES

9
6

Count - Molecule Type

3

Bi o l o gi c S m al l m o l ec u l e To t al R esu l t

BIOLOGYCAL MOLECULES ARE MORE APPROVED

Which sub therapy area have the most expensive drugs?

Price per year or course (FR) 21,700

Sub-Therapy Area Sum - Price per year or course (FR)

Multiple sclerosis 21,700
QUESTION: How many orphan products
How many orphan produ
How many orphanHow
p many orphan products achieved ASMR III in the last

ANSWER: There is only one drug which comes under orphan drug category in given data which was approved in ASMR IV i
so, no drug approved as orphan product achieved ASMR III in last 5 years.

Brand Name INN Name Manufacturer Molecule Type MA date (EMA)

Wakix pitolisant Bioprojet PharmaSmall molecule 3/31/2016

QUESTION: ASMR distribution by time

ANSWER: Count - HAS AssessmenYears

HAS Assessment Outco 1995 1996 1997 1998
ASMR I 1 1
ASMR II 1 1
ASMR III 1
ASMR III,ASMR V
ASMR IV
ASMR IV, ASMR III
ASMR IV,ASMR II
ASMR V 1 1
Not assessed
SMR Insufficient
Total Result 1 1 2 3

QUESTION: List products that achieved an ASMR IV between 2010 and 2018 across all diseases?

ANSWER: Years - multiple -

HAS Assessment Outco Sub-Therapy Area Brand Name (empty)

ASMR IV
Epilepsy
Buccolam
Multiple sclerosis
Gilenya
Narcolepsy
Wakix
QUESTION: ASMR distribution by sub therapy area

ANSWER: HAS Assessment Outco Sub-Therapy Area (empty)

ASMR I
Demyelination
Multiple sclerosis
ASMR II
Amyotropic lateral sclerosis
Multiple sclerosis
ASMR III
Myoclonic seizures
Parkinson’s disease
ASMR III,ASMR V
Multiple sclerosis
ASMR IV
Epilepsy
Lennox Gastaut syndrome
Multiple sclerosis
Narcolepsy
Pain
Parkinson’s disease
Partial-onset seizures
Restless-legs syndrome
Tonic-clonic seizures
ASMR IV, ASMR III
Schizophrenia
ASMR IV,ASMR II
Alzheimers disease
ASMR V
Alzheimers disease
Bipolar disorder
Depression
Multiple sclerosis
Pain
Parkinson’s disease
Partial-onset seizures
Schizophrenia
Tonic-clonic seizures
Not assessed
Anxiety disorder
Insomnia
Parkinson’s disease
SMR Insufficient
Anxiety disorder
s achieved ASMR III in the last 5 years?

was approved in ASMR IV in 2016

Adult/Paediatric Route of HAS Assessment Sub-Therapy

Orphan Status (EMA) Availability Administration Outcome (ASMR) Area Drug class

Orphan Adults only Oral ASMR IV Narcolepsy H3 receptor antagon

2000 2002 2004 2005 2006 2007

1

1 1

1 1 2 2
1
1
3 2 1
1

1 2 4 3 5 3
Price per year or
course (FR)

4,800

2008 2009 2010 2011 2012 2013 2014 2015

1 2

2 1 1 1 1 2 3 1
1
1
4 1 1 3 1 3 3 1
2016 2018 Total Result
3
2
3
1 1
1 10
1
1
1 21
1 3
1
2 2 46
Here is the information of some drugs approved within the space of nervous system. Please use t

THERAPIES INDICATED FOR TREATING DISEASES OF NERVOUS SYSTEM

Brand Name INN Name Manufacturer Molecule Type MA date (EMA)

Abilify aripiprazole Otsuka PharmaceuticaSmall molecule 6/4/2004

Abilify aripiprazole Otsuka PharmaceuticaSmall molecule 3/31/2008

Briviact brivaracetam UCB Pharma Ltd Small molecule 1/13/2016

Extavia interferon beta-1b Novartis Biologic 5/20/2008

Fycompa perampanel Eisai Ltd Small molecule 7/23/2012

Fycompa perampanel Eisai Ltd Small molecule 6/22/2015

Gilenya fingolimod hydrochloNovartis Small molecule 3/17/2011

Inovelon/Banzel rufinamide Eisai Ltd Small molecule 1/16/2007

Keppra levetiracetam UCB Pharma Ltd Small molecule 9/29/2000

Keppra levetiracetam UCB Pharma Ltd Small molecule 8/7/2006

Keppra levetiracetam UCB Pharma Ltd Small molecule 1/4/2007

of nervous system. Please use this table and try to answer the questions mentioned in the second sheet.

Orphan Status (EMA) Adult/Paediatric Availability Route of Administration

Not orphan Both adults and pediatrics Oral

Not orphan Both adults and pediatrics Oral

Not orphan Both adults and pediatrics Oral

Not orphan Both adults and pediatrics Subcutaneous

Not orphan Both adults and pediatrics Oral

Not orphan Both adults and pediatrics Oral

Not orphan Both adults and pediatrics Oral

Not orphan Both adults and pediatrics Oral

Not orphan Both adults and pediatrics Intravenous, Oral

Not orphan Both adults and pediatrics Intravenous, Oral

Not orphan Both adults and pediatrics Intravenous, Oral

questions mentioned in the second sheet.

HAS Assessment Outcome (ASMR) Sub-Therapy Area Drug class Price per year or course (FR)

ASMR IV, ASMR III Schizophrenia Dopamine antagonists 572

ASMR V Bipolar disorder Dopamine antagonists 272

ASMR V Partial-onset seizures Sodium channel antag 913

ASMR V Multiple sclerosis Immunostimulants 8,666

ASMR V Partial-onset seizures AMPA receptor antag 847

ASMR V Tonic-clonic seizures AMPA receptor antag 847

ASMR IV Multiple sclerosis Sphingosine 1 phosph 18,625

ASMR IV Lennox Gastaut syndr Sodium channel antag 1,764

ASMR IV Partial-onset seizures SV2A protein modula 367

ASMR III Myoclonic seizures SV2A protein modula 367

ASMR IV Tonic-clonic seizures SV2A protein modula 367

 Sl No

You can prepare pivot charts and tables to answer the questions and please paste the tables/graphs in a new sheet
 GENERAL QUESTIONS

List of drugs indicated for both adults and pediatrics among the drugs indicated for CNS?

List the products by sub therapy area (products by individual therapy area)

List the major companies that have products approved in bipolar disorder

Which diseases are considered as orphan?

How many orphan drugs were approved by EMA in each year between 2015 and 2018?

List the products that currently have a price higher than 10000 euros per year and in what indications among the
drugs indicated for CNS?

Average cost of treatment by sub therapy

How many small molecules and biologics were approved for multiple sclerosis?

Which sub therapy area have the most expensive drugs?

You can prepare pivot charts and tables to answer the questions and please paste the tables/graphs in a new sheet
 FRANCE SPECIFIC QUESTIONS

How many orphan products achieved ASMR III in the last 5 years?

ASMR distribution by time

List products that achieved an ASMR IV between 2010 and 2018 across all
diseases?

ASMR distribution by sub therapy area