Interferon alfacon-1 was first approved by the U.S. Food and Drug Administration (FDA) on October 6, 1997, then approved by European Medicine Agency (EMA) on February 1, 1999. It was originally developed by Amgen, then developed and marketed by Astellas, and now marketed as Infergen® by Kadmon in US.
Interferon alfacon-1 is a wholly synthetic type-I interferon, which induces pleiotropic biologic responses, including antiviral, antiproliferative and immunomodulatory effects. It is indicated for the treatment of chronic hepatitis C in patients 18 years of age or older with compensated liver disease.
Infergen® is available as injection (solution) for subcutaneous use, containing 9 mcg/0.3 mL or 15 mcg/0.5 mL of Interferon alfacon-1. The recommended dose is 9 mcg three times weekly for monotherapy, 15 mcg daily for combination treatment.
Withdrew on 2006 in EU by Astellas due to commercial reasons.
Update Date:2016-01-15
Update Date:2016-01-15
Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
---|---|---|---|---|---|---|---|
1997-10-06 | First approval | Infergen | HCV infection | Injection, Solution | 9 mcg/0.3 mL; 15 mcg/0.5 mL | Kadmon |
Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
---|---|---|---|---|---|---|---|
1999-02-01 | Marketing approval | Infergen | HCV infection | Injection | 9 mcg/0.3 mL; 15 mcg/0.5 mL | Astellas |
Update Date:2015-09-07
Type | Recombinant cytokines | |
Source | Human | |
Molecular Formula | C860H1353N227O255S9 | |
Molecular Weight | 19434 | |
CAS No. | 118390-30-0 | |
Expression System | E.coli |