Who makes OLYSIO?
TITUSVILLE, N.J. (November 22, 2013) – Janssen Therapeutics, Division of Janssen Products, LP (Janssen), announced today the U.S. Food and Drug Administration (FDA) has approved OLYSIO™ (simeprevir), an NS3/4A protease inhibitor, for the treatment of chronic hepatitis C infection as part of an antiviral treatment …
What is OLYSIO used for?
OLYSIO® is indicated for the treatment of adults with chronic hepatitis C virus (HCV) infection [see DOSAGE AND ADMINISTRATION and Clinical Studies]: in combination with sofosbuvir in patients with HCV genotype 1 without cirrhosis or with compensated cirrhosis.
When was Simeprevir approved?
Simeprevir was approved in September 2013 in Japan, in November 2013 in Canada and the U.S., in March 2014 in Russia, and in July 2014 in Mexico and Australia. In May 2014 simeprevir was granted marketing authorization by the European Commission (EC) (indications vary by market).
Is Olysio discontinued?
Simeprevir (Olysio) Discontinued. Discontinued. This treatment has been discontinued.
What is the cost of Vosevi?
Official Answer. Vosevi costs approximately $930 per tablet. A 4-week treatment course is approximately $26,026, an 8-week course is approximately $52,052 and a 12-week course is $78,078.
What is the brand name of ribavirin?
Ribavirin is an antiviral medication used together with an interferon alfa product (such as Peg-Intro or Intron A) to treat chronic hepatitis C. Ribavirin is available under the following different brand names: Rebetol, Ribasphere, RibaPak, Copegus, Virazole, and Moderiba.
What is Olysio approved for?
Olysio Approval History. Company: Janssen Pharmaceuticals, Inc. Olysio (simeprevir) is a protease inhibitor for the treatment of chronic hepatitis C virus infection.
Is Olysio FDA approved for hepatitis C?
Olysio Approval History. FDA Approved: Yes (First approved November 22, 2013) Brand name: Olysio Generic name: simeprevir Dosage form: Capsules Company: Janssen Pharmaceuticals, Inc. Treatment for: Hepatitis C Olysio (simeprevir) is a protease inhibitor for the treatment of chronic hepatitis C virus infection.
Who owns the worldwide marketing rights to Olysio™?
Janssen is responsible for the global clinical development of OLYSIO™ and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB will retain marketing rights for OLYSIO™ in these countries under the marketing authorization held by Janssen-Cilag International NV.
Should Olysio be discontinued?
Discontinuation of Olysio should be considered if a photosensitivity reaction occurs and patients should be monitored until the reaction has resolved. If a decision is made to continue Olysio in the setting of a photosensitivity reaction, expert consultation is advised.