The 'adaptive pathway' saves 3-8 years of time for new treatments. EU, green light for new AbbVie anti-hepatitis C mix
Barbara Di Chiara – 19 January 2015- PharmaKronos
The 'adaptive pathway' saves 3-8 years of time for new treatments “Thirty-four molecules approved in Europe in 2014 and 91 in the United States: a similar number not seen since 1991. Drugs for Alzheimer's are arriving and new products for hepatitis C that Aifa is already starting to negotiate. And there is the possibility that HIV could also be eradicated, based on the principles that worked for HCV. There has never been so much pharmaceutical innovation as in this moment”. The picture was outlined by the director general of the Italian drug agency, Luca Pani, speaking at the conference 'Biotechnologies for health: innovation, skills and sustainability' organized in Rome by the High school of economics and management of health systems (Altems) of the Catholic university.
Pani also spoke of the 'adaptive path', a new approval process for new medicines used by AIFA which "was designed to facilitate the approval of innovative medicines", and which allows partial go-ahead "from 3 to 8 years before the current standard.
This process cannot be applied to all molecules, it does not replace the traditional one, but it supports it and helps to cut times. As of December, we have received 29 application requests, we have screened 9, with many orphan drugs or advanced therapies.”
EU, green light for new AbbVie anti-hepatitis C mix
One of the medicines is produced in Italy at the Campoverde plant for the whole world
New entry in the arsenal of innovative hepatitis C products. AbbVie has announced the green light from the European Commission to market its all-oral, interferon-free, short-acting treatment regimen consisting of Viekirax (ombitasvir /paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets).
The treatment, based on a 'mix' of molecules, has been approved for use with or without ribavirin for patients suffering from chronic infection with genotype 1 hepatitis C virus. In addition, one of the drugs included in the treatment (dasabuvir tablets) is produced in Italy, in the Campoverde di Aprilia (Latina) plant for the whole world.
The green disc includes patients with HCV type 1 who have compensated cirrhosis of the liver, are co-infected with HIV-1, are receiving opioid substitution therapy, and have received liver transplantation. In addition, Viekirax has received approval for use together with ribavirin in patients with genotype 4 chronic hepatitis C. “The approval in the European Union, which adds to recent approvals granted in the United States and Canada, it allows us to offer patients across Europe a new and effective treatment for this serious disease,” said Richard Gonzalez, Chairman of the Board of Directors and Chief Executive Officer of AbbVie.
"Our commitment is to work alongside governments and national health systems of the various countries to allow access" to the medicine "to as many patients as possible". These approvals are the result of a shortened evaluation process foreseen by the European Medicines Agency for new medicines of particular public health interest.
About nine million people in Europe alone are affected by chronic hepatitis C, a disease that is one of the main causes of liver cancer and liver transplantation. Furthermore, genotype 1 is the most prevalent form of hepatitis C in Europe, and is observed in 60% of cases worldwide.
The AbbVie proprietary treatment is currently approved for use in all 28 EU member states, as well as the United States, Canada, Switzerland, Iceland, Liechtenstein and Norway. "Hepatitis C is a complex disease, characterized by different genotypes and a variety of patient populations, factors that must be taken into account when identifying the appropriate treatment for each individual patient," explains Stefan Zeuzem of JW Goethe University Hospital in Frankfurt, Germany.
“In clinical trials, AbbVie's treatment has achieved high cure rates associated with low treatment discontinuation rates in diverse patient populations, making it a crucial addition to therapies that are revolutionizing hepatitis C treatment.” .
The studies demonstrated the compound's ability "to cure 95%-100% of patients with genotype 1 hepatitis C who received the recommended regimen, experiencing virologic failure in a lower proportion of patients than 2%."
Margherita Lopes- January 19, 2015- PharmaKronos
