Olysio simeprevir regulatory update
The Scottish Medicines Consortium recommended Olysio simeprevir from Medivir and Johnson & Johnson's Janssen Research & Development LLC unit in combination with other therapies to treat HCV genotype 1 and 4 infection in previously treated adults and adults who have failed previous treatment. Separately, Janssen proposed a "Pay If You Clear" reimbursement scheme to NHS Scotland, in which the company would cover Olysio's cost to patients who do not achieve a sustained virologic response 12 weeks after treatment. A formal decision on the cost-sharing scheme by NHS Scotland is pending. The European Commission approved Olysio in May to treat HCV genotypes 1 and 4 infection in combination with peginterferon, ribavirin and/or Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD, Foster City, Calif.). J&J plans to launch Olysio in the EU by year end. ...