Update from GMP – Malaria
Prevention, Diagnostics and Treatment
Interagency Pharmaceutical Coordination (IPC) Group Meeting
World Bank, Washington, USA, 6-7 June 2016
Silvia Schwarte
Prevention, Diagnostics and Treatment
e-mail: [email protected]
Outline
Past trends, current achievements, future goals
Prevention
 RTS,S/AS01 vaccine
Diagnosis
 Round 6 Report – WHO selection criteria product update
 Procurement criteria – WHO PQ
Treatment
 New quality-assured medicines
MDG 6 target – to halt and reverse the incidence of
malaria – has been achieved
Global Technical Strategy 2016-2030
20 April 2016: The WHO European Region is malaria free
Ahead of World Malaria Day 2016, WHO announces that
the European Region hit its 2015 target to wipe out malaria,
thus contributing to the global goal to "End malaria for good".
RTS,S/AS01 malaria vaccine
 Jul 2015: Positive Scientific Opinion by EMA (Article 58)
 Oct 2015: SAGE / MPAC: evidence review for global policy
recommendation => large-scale implementation pilots
 parts of 3-5 sub-Saharan African countries
 administering 3 doses of the vaccine to children aged 5-9 months
with a fourth dose 15-18 months later
 mortality impact
 meningitis and cerebral malaria
=> pilots to generate evidence for decision-making about
potential wider scale use of RTS,S in 3-5 years' time
 Jan 2016: WHO issues first position paper on a malaria
vaccine (http://www.who.int/entity/wer/2016/wer9104.pdf?ua=1)
Performance evaluation of malaria RDTs:
Round 6 report published – WHO selection criteria updated
Changes to WHO criteria on RDT procurement (I)
http://www.who.int/diagnostics_laboratory/evaluations/en/
12 malaria RDTs from 4 manufacturers are
WHO prequalified:
Products accessible at:
http://www.who.int/malaria/news/
 7 Pf-only
2016/rdt-procurement-criteria/en/
 4 Pf and non-Pf
 1 all species (but does not distinguish
between them)
Test name
Manfacturer
2014 MS
(w/in
category)
2014 MS Prequalified
(overall) date
Pf Only
1 CareStartTM Malaria HRP2 (Pf)
2 First Response® Malaria Ag P. falciparum (HRP2) Card Test
3 ParaHIT f Ver. 1.0 Rapid Test for P.falciparum Malaria Dipstick
4 ParaHIT f Ver. 1.0 Rapid Test for P.falciparum Malaria Device
5 SD BIOLINE Malaria Ag P.f
Access Bio
PMC
Span/Arkray
Span/Arkray
Alere/SD
34%
15%
0%
3%
41%
93%
21%
9%
Pf/pan
1 Carestart pf/pan Combo
2 SD BIOLINE Malaria Ag P.f/Pan
Access Bio
Alere/SD
12%
72%
84%
4%
21%
24%
28-May-15
8-Jul-13
Pf/pv
1 CareStartTM Malaria HRP2/pLDH (Pf/Pv) COMBO
2 SD BIOLINE Malaria Ag P.f/P.v
Access Bio
Alere/SD
6%
94%
100%
0%
5%
6%
28-May-15
16-Oct-15
2%
0%
1%
3%
28-May-15
28-May-15
16-Oct-15
Other
1 CareStartTM Malaria HRP2/pLDH (Pf)
2 CareStartTM Malaria pLDH (PAN)
3 SD BIOLINE Malaria Ag P.f (HRP2/pLDH)
12
Access Bio
Access Bio
Alere/SD
2%
26%
58%
28-May-15
25-Feb-15
7-Oct-14
7-Oct-14
6-Dec-10
Changes to WHO criteria on RDT procurement (II)
Timelines
 For products that are currently eligible for WHO
procurement, manufacturers must submit a WHO PQ presubmission form to WHO PQT by 31 July 2016.
 For products that are new to WHO processes or for products
that are due for compulsory resubmission to Product Testing,
manufacturers must submit to the revised EOI for Round 8, in
quarter 4 of 2016.
 Manufacturers are expected to have submitted a complete
dossier for each product to WHO PQT by 31 December 2016.
 Manufacturers are expected to complete full prequalification
by 31 December 2017. Beyond this date only prequalified
products will be recommended and eligible for WHO
procurement.
Quality-assured antimalarial medicines (last updated 3 June 2016)
 Fixed-dose combinations (FDCs)
- AL 20/120mg:
- AL 20/120mg dispersibles:
- AL 40/240mg:
- AL 80/480mg:
- ASAQ:
- ASMQ:
- DHA-PPQ (20/160mg, 40/320mg):
Ajanta, Cipla, Ipca, Macleods, Mylan, Novartis, Strides
Ajanta, Novartis
Mylan
Novartis
Ajanta, Cipla, Guilin, Ipca, Sanofi
DNDi/Cipla
Sigma-Tau
 Co-Blisters (Co-B)
- AS + AQ:
- AS + SP:
Cipla, Guilin, Ipca, Strides
Guilin
 Injectables
- AS (30/60/120mg)powder for inj: Guilin




SP + AQ (76.5+25012.5mg, 153+500/250mg): Guilin
Primaquine (7.5mg, 15mg):
Remedica, Sanofi
Chloroquine:
Alliance Pharma, Remedica, Sanofi
SP (500/25mg):
Guilin, Remedica
Thank you very much
for your attention
Backup slides
WHO prequalified malaria RDTs
Test name
Manfacturer
2014 MS
(w/in
category)
2014 MS Prequalified
(overall) date
Pf Only
1 CareStartTM Malaria HRP2 (Pf)
2 First Response® Malaria Ag P. falciparum (HRP2) Card Test
3 ParaHIT f Ver. 1.0 Rapid Test for P.falciparum Malaria Dipstick
4 ParaHIT f Ver. 1.0 Rapid Test for P.falciparum Malaria Device
5 SD BIOLINE Malaria Ag P.f
Access Bio
PMC
Span/Arkray
Span/Arkray
Alere/SD
34%
15%
0%
3%
41%
93%
21%
9%
Pf/pan
1 Carestart pf/pan Combo
2 SD BIOLINE Malaria Ag P.f/Pan
Access Bio
Alere/SD
12%
72%
84%
4%
21%
24%
28-May-15
8-Jul-13
Pf/pv
1 CareStartTM Malaria HRP2/pLDH (Pf/Pv) COMBO
2 SD BIOLINE Malaria Ag P.f/P.v
Access Bio
Alere/SD
6%
94%
100%
0%
5%
6%
28-May-15
16-Oct-15
2%
0%
1%
3%
28-May-15
28-May-15
16-Oct-15
Other
1 CareStartTM Malaria HRP2/pLDH (Pf)
2 CareStartTM Malaria pLDH (PAN)
3 SD BIOLINE Malaria Ag P.f (HRP2/pLDH)
12
Access Bio
Access Bio
Alere/SD
2%
26%
58%
28-May-15
25-Feb-15
7-Oct-14
7-Oct-14
6-Dec-10