Vitravene (fomivirsen) is the first antisense drug to achieve marketing
clearance. Vitravene treats a condition called cytomegalovirus (CMV)
retinitis in people with AIDS. Isis developed the drug and licensed
the worldwide commercial rights to Novartis Ophthalmics (formerly
CibaVision.)
Vitravene’s approval was important to Isis and to antisense
technology in a variety of ways:
1.
It demonstrated that antisense drugs are effective
in the treatment of local disease.
2.
It demonstrated that antisense
drugs could gain marketing approval by the U.S. Food and
Drug Administration (FDA) and regulatory agencies around
the world.
3.
It demonstrated that antisense
drugs can be manufactured for commercial use and that Isis
is capable of meeting the criteria of the FDA and European
regulators as a manufacturer of pharmaceuticals. Isis continues
to be the commercial manufacturer of Vitravene.
