BioCryst (BCRX) Higher After Peramivir Granted Emergency Use Authorization
Late Friday, BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that the FDA, in response to a request from the U.S. Centers for Disease Control and Prevention (CDC), has issued an emergency use authorization for the investigational anti-viral drug intravenous peramivir in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.
Specifically, i.v. peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an i.v. drug is clinically appropriate, based on one or more of the following reasons:
Shares of BioCryst are up 19% in pre-open trading.
Specifically, i.v. peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an i.v. drug is clinically appropriate, based on one or more of the following reasons:
- 1. the patient is not responding to either oral or inhaled anti-viral therapy, or
- 2. when drug delivery by a route other than an intravenous route -- e.g., enteral (absorbed by the intestines) or inhaled -- is not expected to be dependable or feasible;
- 3. for adults only, when the clinician judges i.v. therapy is appropriate due to other circumstances.
Shares of BioCryst are up 19% in pre-open trading.
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