Drug Analysis: Betaseron

Drug Analysis: Betaseron

  • November 2017 •
  • 15 pages •
  • Report ID: 5336315 •
  • Format: PDF
Drug Overview
Betaseron was the first drug to reach the market that modifies the course of multiple sclerosis (MS), after launching in the US in 1994 and the EU in 1996 (where it is marketed as Betaferon). At the time, Betaseron was granted orphan drug status because of its ability to curb MS disease progression as well as reduce the frequency of attacks.

However, the US Food and Drug Administration overturned this decision, allowing Avonex (interferon beta-1a; Biogen) to come to market in 1996. In November 2000, Betaseron became the first MS disease modifier to launch in Japan, where it was also granted orphan drug status.

Betaseron is delivered via subcutaneous injection, and was originally developed by Chiron Corporation (a division of Novartis). It is indicated for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations, as well as for treating secondary progressive multiple sclerosis (SPMS) in the EU. In 2006, Betaseron’s label was extended in both the EU and US to include the treatment of patients with a first clinical event suggestive of MS.