Gilead Sciences much-touted hepatitis C virus treatment Sovaldi has been recommended for approval in Europe, with a broad label that suggests it could encompass a large number of uses.
The Committee for Medicinal Products for Human use (CHMP) has said Sovaldi (sofosbuvir) should be approved for use “in combination with other medicinal products for the treatment of chronic hepatitis C in adults”.
Sofosbuvir is the first compound in the NS5B polymerase inhibitor class to reach this phase of development, and looks set to become a major new earner for Gilead, cementing its position in the antiviral drugs sector.
The CHMP noted that trials had “shown convincingly” that sofosbuvir in combination with ribavirin was effective and safe, taking Gilead another step closer to launching the first drug regimen for chronic hepatitis C that does not require interferon, improving compliance and tolerability.
In a statement, the European Medicines Agency (EMA) said the prevalence of hepatitis C infection ranges from 0.4 to 3.5 per cent among the European member states.
Last month, a US FDA advisory panel gave its blessing to sofosbuvir, saying it was effective with ribavirin alone for patients with genotypes 2 and 3 and also recommended approval alongside pegylated interferon for the more prevalent genotype 1 form of the infection. The US regulator is due to deliver its verdict by December 7.
The CHMP said that when sofosbuvir is used in combination with pegylated interferon as well as ribavirin, it can shorten treatment duration down to 12 weeks from 24-48 weeks, noting “this is of value considering the side effect profile of interferon”.
Other orally-active agents – namely the protease inhibitor class represented by Johnson & Johnson/Vertex/Mitsubishi Tanabe’s Incivek/Incivo (telaprevir) and Merck & Co’s Victrelis (boceprevir) – are being used alongside pegylated interferon and ribavirin to boost response rates, but a sizeable proportion of hepatitis C patients are unable to tolerate the interferon component.
Analysts have suggested sofosbuvir’s clinical profile – coupled with being likely first to market – could make it a mega-blockbuster with sales up to $5bn a year at peak, although Gilead is expected to face competition quickly from other quarters.
Other players developing interferon-free regimens include AbbVie , Bristol-Myers Squibb, Boehringer Ingelheim, Merck and Vertex, as well as some smaller biopharma companies.
Daclatasvir backed for compassionate use
Meanwhile, the CHMP also gave a green light to the use of a combination of sofosbuvir with Bristol-Myers Squibb’s NS5A inhibitor daclatasvir via a compassionate-use programme.
The decision would make a regimen of daclatasvir and sofosbuvir – with or without ribavirin – available to adults with genotype 1 hepatitis C who are at a high risk of their liver being no longer able to function normally or death within 12 months if left untreated