Update on the Global Use of Bedaquiline and Delamanid for Programma9c Management of DrugResistant Tuberculosis
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Update on the Global Use of Bedaquiline and Delamanid
for Programma9c Management of Drug-‐Resistant Tuberculosis
DR-‐TB STAT Task Force • Formed in April 2015 in response to the “Call to Ac9on” to accelerate access to new drugs for MDR-‐TB*
• Officially adopted as a Global DR-‐TB Ini9a9ve task force in July 2015
• Mul9agency par9cipa9on
• Collects informa9on from Na9onal TB Programs each month on the use of BDQ and DLM
• Provides technical assistance and support for countries to overcome barriers to new drug introduc9on
• Data current to 1 September 2016 • See more at www.drtb-‐stat.org
*hWp://www.msfaccess.org/content/call-‐ac9on-‐accelerate-‐access-‐dr-‐tb-‐drugs
New Drugs for DR-‐TB treatment
• Bedaquiline • Delamanid
Bedaquiline (BDQ) Delamanid (DEL) Rx length, pills 6 months, 188 pills (100 mg tablet) 6 months, 672 pills (50 mg tablet)
Indica9on MDR-‐TB (WHO Essen9al Medicines List) MDR-‐TB (WHO Essen9al Medicines List)
WHO EML Yes Yes
Registra9on Restricted use pre-‐XDR/XDR Condi9onal approval Registered in 7 countries and pending in 9/27 high burden countries
Broader recommenda9on for MDR-‐TB Condi9onal approval Registered in Japan, S. Korea, Hong Kong, European Union
Patent Status Intellectual property barriers (compound and mul9ple secondary patents) un9l 2029
Intellectual property barriers (compound and mul9ple secondary patents) un9l 2031
Voluntary licensing?
Not clear if Janssen with engage in bilateral or MPP-‐led voluntary license nego9a9ons
No advance on poten9al voluntary licenses for generic companies
Compe99on No No
QA supplier 1 (Janssen) 1 (Otsuka)
GDF price (PPPM) $0 through GDF* 6-‐month supply: $900 LIC; $3000 MIC; $30,000 UIC
$1,700 for 6-‐month supply*
Target price range (USD)*
$8.80 -‐ $16.40 / month $3.50 -‐ $8.60 / month
‘Access policies’ Dona9on April 2015: 30,000 courses/4 years for Global Fund-‐eligible countries; quota for CIS countries; CU program phased out in 2015
Dona9on announced April 2015: 20% of MDR-‐TB pa9ents by 2020; no informa9on available
Timeline: introduc9on of new DR-‐TB drugs
28 December 2012 FDA grants accelerated approval for bedaquiline
June 2013 WHO releases interim guidelines for use of bedaquiline to treat DR-‐TB
6 March 2014 EMA condi9onally approves bedaquiline
30 April 2014 EMA condi9onally approves delamanid
October 2014 WHO releases interim guidelines for use of delamanid to treat DR-‐TB
May 2015 WHO adds bedaquiline and delamanid to model EML
1 April 2015 Janssen/USAID launch bedaquiline dona9on program
April 2015 Otsuka announces FighTBack Ini9a9ve program
October 2015 Georgia becomes first country to receive donated bedaquiline
Bedaquiline progress • 5234 pa9ents enrolled as of 1 September 2016 (60% in South Africa, 20% in
Russia)
• 4663 orders from GDF
• As of 1 May 2016, BDQ has been registered with 12 regulatory authori9es (Armenia, the European Union, India, Macau, Peru, Philippines, Russia, South Africa, South Korea, Taiwan, Turkmenistan, the United States, and Uzbekistan)
• Dossiers have been submiWed to an addi9onal 17 countries
0
1000
2000
3000
4000
5000
6000
Jul-‐15 Aug-‐15 Sep-‐15 Oct-‐15 Nov-‐15 Dec-‐15 Jan-‐16 Feb-‐16 Mar-‐16 Apr-‐16 May-‐16 Jun-‐16 Jul-‐16 Aug-‐16 Sep-‐16
BDQ
Global BDQ implementa9on
* As of 1 September 2016
Delamanid progress • 366 pa9ents on DLM, all in MSF or PIH sites • 1018 orders from GDF • DLM registered in Japan, South Korea, Hong Kong, the European Union
– not registered in any MDR-‐TB high-‐burden countries
• Dossiers have been submiWed for registra9on in the Philippines, Indonesia, Turkey – Other submission in progress in Vietnam, China, South Africa
0
50
100
150
200
250
300
350
400
DLM
Global DLM implementa9on
* As of September 1, 2016
Global Progress: BDQ and DLM
0
1000
2000
3000
4000
5000
6000
Jul-‐15 Aug-‐15 Sep-‐15 Oct-‐15 Nov-‐15 Dec-‐15 Jan-‐16 Feb-‐16 Mar-‐16 Apr-‐16 May-‐16 Jun-‐16 Jul-‐16 Aug-‐16 Sep-‐16
BDQ
DLM
BDQ and DLM versus minimum es9mated global need
0
5000
10000
15000
20000
25000
30000
35000
Jul-‐15 Aug-‐15 Sep-‐15 Oct-‐15 Nov-‐15 Dec-‐15 Jan-‐16 Feb-‐16 Mar-‐16 Apr-‐16 May-‐16 Jun-‐16 Jul-‐16 Aug-‐16 Sep-‐16
BDQ
DLM
Goal
References 1. Médecins Sans Fron9ères Out of Time: Access to Treatment for DR-‐TB. MSF Briefing
Document, December 2015. 2. Gotham D et al. Target generic prices for novel treatments for drug-‐resistant
tuberculosis. 15th European AIDS Conference, Barcelona, abstract PS2/4 2015. 3. Médecins Sans Fron9ères DR-‐TB Drugs Under the Microscope, 2016. 4. Brigden G, Hewison C, Varaine H. New developments in the treatment of drug-‐
resistant tuberculosis: Clinical u9lity of bedaquiline and delamanid. Infec9on and Drug Resistance 8: 367-‐378, 2015.
5. hWp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm333695.htm 6. hWp://www.who.int/tb/publica9ons/WHO_BDQimplementa9onplan.pdf 7. hWps://www.jnj.com/news/all/SIRTURO-‐bedaquiline-‐Receives-‐Condi9onal-‐Approval-‐
in-‐the-‐European-‐Union-‐for-‐the-‐Treatment-‐of-‐Mul9-‐Drug-‐Resistant-‐Tuberculosis 8. hWp://www.businesswire.com/news/home/20140429006457/en/Otsuka-‐Wins-‐
European-‐Marke9ng-‐Authoriza9on-‐Deltyba%E2%84%A2-‐delamanid#.U2EqM1VdXKM 9. hWp://www.who.int/tb/publica9ons/delamanid-‐in-‐mdr-‐tb-‐treatment/en/ 10. hWp://www.who.int/mediacentre/news/releases/2015/new-‐essen9al-‐medicines-‐list/
en/ 11. hWp://siapsprogram.org/2016/01/13/8006/ 12. hWp://www.who.int/tb/features_archive/otsuka_2015/en/ 13. hWp://siapsprogram.org/2015/10/13/drug-‐safety-‐and-‐monitoring-‐are-‐key-‐as-‐
bedaquiline-‐dona9on-‐program-‐launches-‐in-‐georgia/ 14. hWp://www.who.int/tb/publica9ons/delamanid-‐in-‐mdr-‐tb-‐treatment/en/ 15. hWps://www.jnj.com/news/all/SIRTURO-‐bedaquiline-‐Receives-‐Condi9onal-‐Approval-‐
in-‐the-‐European-‐Union-‐for-‐the-‐Treatment-‐of-‐Mul9-‐Drug-‐Resistant-‐Tuberculosis
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