MedImmune Inc. said yesterday it has filed for approval from the Food and Drug Administration to market in the United States its new drug to prevent a common infant respiratory disease.
The move has been anticipated for some time by analysts.
The Gaithersburg-based company said it has selected Synagis as the trade name for the drug, developed to prevent serious respiratory syncytial virus, or RSV, disease in infants and young children.
Before the FDA makes a decision on the request, an advisory body must hold a public hearing on the proposal.
That meeting might not be scheduled for weeks.
If approved by the FDA, Synagis would be marketed by pharmaceutical giant Abbott Laboratories, which licensed sales rights earlier this month.
The company anticipates seeking European marketing clearances early next year.
The biotechnology company will get a $30 million payment if Synagis receives marketing approvals from U.S. and European regulatory agencies, and another $15 million payment when certain sales levels for the drug are achieved.
Shares in MedImmune rose 37.5 cents to close at $40.875 on the Nasdaq stock exchange yesterday.
Pub Date: 12/20/97