SAN FRANCISCO, November 12, 2018
SAN FRANCISCO, November 12, 2018 /PRNewswire/ --
The Medicines Patent Pool (MPP) has announced a new, royalty-free licence agreement with AbbVie for glecaprevir/pibrentasvir (G/P) - a World Health Organization (WHO)-recommended treatment for people living with chronic hepatitis C (HCV). The licence will enable quality-assured manufacturers to develop and sell generic medicines containing G/P in 99 low- and middle-income countries (LMICs) and territories at affordable prices, enabling access to and treatment scale-up with the most effective pan-genotypic regimens.
"G/P is a priority therapy for licensing for the MPP, so this agreement with AbbVie is good news for public health," said Dr Marie-Paule Kieny, Chair of the MPP Governance Board. “It is a really important new option for a significant proportion of HCV patients throughout the world. As with previous MPP licences, we look forward to facilitating access to generic versions of this product as quickly as possible in as many territories as possible.”
Globally, 71 million people are currently living with chronic HCV, many of them in LMICs. By the end of 2015, only 20 percent had been diagnosed and a mere seven percent of them had received treatment.
G/P is an all-oral, once-daily, pan-genotypic combination regimen and was originally approved in 2017. It has achieved high cure (SVR12) rates of 98 percent in treatment-naïve non-cirrhotic patients across all six genotypes of the virus. It is recommended by the WHO as a first-line treatment for eight weeks for treatment-naïve non-cirrhotic patients.
Further, the regimen is also indicated for use in HCV patients with any degree of renal impairment, including patients on dialysis. There are 95 countries and four territories included in the MPP/AbbVie licence for G/P at this point.
"The Government of Pakistan warmly welcomes the agreement between the Medicines Patent Pool and AbbVie to expand access to glecaprevir/pibrentasvir - a very important therapy for the treatment of HCV - into territories including Pakistan. The HCV burden in Pakistan is endemic, affecting over eight million of our country's population and the prevention and treatment of HCV is a national priority. This agreement will considerably aid our efforts and, ultimately, accelerate the permanent elimination of the HCV virus."
Mr Aamer Mehmood Kianai, Ministry of National Health Services, Regulations and Coordination, Government of Pakistan
"The new agreement is an important step towards achieving elimination of hepatitis C worldwide. We urge national governments to take action now to make such curative treatments available for the millions of people in need."
Dr Gottfried Hirnschall, Director of Department of HIV and Global Hepatitis Programme, World Health Organization
About the Medicines Patent Pool
The Medicines Patent Pool is a United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries. Through its innovative business model, the MPP partners with civil society, governments, international organisations, industry, patient groups and other stakeholders, to prioritise and license needed medicines and pool intellectual property to encourage genetic manufacture and the development of new formulations. The MPP was founded and is funded by Unitaid.