Medivir has announced that its NS3/4A protease inhibitor Olysio will be available in all of the Nordic countries within the next few weeks.
Treatment with Olysio began in Sweden in late May, followed by Finland and Denmark, where the first patients recently began their treatment.
“It is immensely gratifying to now be able to offer a new and much sought-after treatment option for hepatitis C patients in the Nordic region. The growing awareness of Olysio and other new antivirals has been welcomed by doctors, who now have access to safer, more effective treatment options. Our Nordic commercial organisation has been carefully built up and is staffed by people with a track record of successful specialist care launches. Our aim is to continue adding new and innovative specialist care pharmaceuticals to our product portfolio. In the spring of this year, we launched not only Olysio, but also Adasuve (a psychiatric pharmaceutical for the treatment of agitation). It is a fantastic feeling to work with such a competent launch team and receive regular positive feedback from the health care sector on the ways in which these new treatment options offer great value for the patients,” says Henrik Krook, EVP Commercial, Medivir.
The marketing authorisation granted by the European Commission in mid-May represents a significant milestone in the development of new triple therapy hepatitis C treatment options for genotype 1 and 4 patients, stated Medivir. It also includes Olysio as part of an all oral 12-week interferon-free direct-acting antiviral (DAA) regimen with or without ribavirin (RBV), in genotype 1 or 4 patients, who are intolerant to or ineligible for IFN treatment.
The European Commission approval for Olysio with PegIFN + RBV is based on a clinical trial programme involving three pivotal phase III studies, QUEST-1, QUEST-2 and PROMISE. The use of Olysio in combination with sofosbuvir was also approved on the basis of, amongst others, the COSMOS clinical phase II study. This study enrolled treatment-naïve patients who were prior null responders. Patients with fibrosis or cirrhosis of the liver were evaluated in all of these studies with very good efficacy and safety data.