Update on the Global Use of Bedaquiline and Delamanid for Programma9c Management of Drug- Resistant Tuberculosis

Transcription

1 Update on the Global Use of Bedaquiline and Delamanid for Programma9c Management of Drug- Resistant Tuberculosis

2 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 stat.org *hwp:// ac9on- accelerate- access- dr- tb- drugs

3 New Drugs for DR- TB treatment Bedaquiline Delamanid

4 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 Patent Status Voluntary licensing? Restricted use pre- XDR/XDR Condi9onal approval Registered in 7 countries and pending in 9/27 high burden countries Intellectual property barriers (compound and mul9ple secondary patents) un9l 2029 Not clear if Janssen with engage in bilateral or MPP- led voluntary license nego9a9ons Compe99on No No QA supplier 1 (Janssen) 1 (Otsuka) Broader recommenda9on for MDR- TB Condi9onal approval Registered in Japan, S. Korea, Hong Kong, European Union Intellectual property barriers (compound and mul9ple secondary patents) un9l 2031 No advance on poten9al voluntary licenses for generic companies GDF price (PPPM) Target price range (USD)* Access policies $0 through GDF* 6- month supply: $900 LIC; $3000 MIC; $30,000 UIC $1,700 for 6- month supply* $ $16.40 / month $ $8.60 / month 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

5 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

6 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 BDQ 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

7 Global BDQ implementa9on * As of 1 September 2016

8 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 DLM

9 Global DLM implementa9on * As of September 1, 2016

10 Global Progress: BDQ and DLM BDQ DLM 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

11 BDQ and DLM versus minimum es9mated global need BDQ DLM Goal 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

12 References 1. Médecins Sans Fron9ères Out of Time: Access to Treatment for DR- TB. MSF Briefing Document, December Gotham D et al. Target generic prices for novel treatments for drug- resistant tuberculosis. 15 th European AIDS Conference, Barcelona, abstract PS2/ Médecins Sans Fron9ères DR- TB Drugs Under the Microscope, 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: , hwp:// 6. hwp:// 7. hwps:// bedaquiline- Receives- Condi9onal- Approval- in- the- European- Union- for- the- Treatment- of- Mul9- Drug- Resistant- Tuberculosis 8. hwp:// Wins- European- Marke9ng- Authoriza9on- Deltyba%E2%84%A2- delamanid#.u2eqm1vdxkm 9. hwp:// in- mdr- tb- treatment/en/ 10. hwp:// essen9al- medicines- list/ en/ 11. hwp://siapsprogram.org/2016/01/13/8006/ 12. hwp:// 13. hwp://siapsprogram.org/2015/10/13/drug- safety- and- monitoring- are- key- as- bedaquiline- dona9on- program- launches- in- georgia/ 14. hwp:// in- mdr- tb- treatment/en/ 15. hwps:// bedaquiline- Receives- Condi9onal- Approval- in- the- European- Union- for- the- Treatment- of- Mul9- Drug- Resistant- Tuberculosis