Intravenous (IV) H1N1 swine flu drug peramivir approved for emergency use in US: Biocryst

Intravenous (IV) H1N1 swine flu drug peramivir from BioCryst Pharmaceuticals, Inc. has been given approval to use in emergencies by US FDA.

Peramivir has been issued an emergency use authorization (EUA) for the in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital by the U.S. Food and Drug Administration (FDA), in response to a request from the U.S. Centers for Disease Control and Prevention (CDC), Biocrsyst announced in a press release.

Peramivir is an anti-viral agent which inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host.

Peramivir has shown activity against pandemic H1N1 swine flu origin viral strains, in laboratory tests.

Peramivir has been studied in patients with complicated and uncomplicated influenza. BioCryst’s partner, Shionogi & Co., Ltd. is currently preparing to file for regulatory approval in Japan this year.

Paramivir also has an advantage over oseltamivir and zanamivir as it is administered directly as intravenous injection into the blood stream, allowing it to be effective more rapidly. Relenza is usually inhaled, while Tamiflu comes in pill form.

Intravenous (IV) 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.

“The issuance of this EUA is important because it makes peramivir a treatment option for physicians in the U.S. during the ongoing influenza health emergency,” said Jon P. Stonehouse, Chief Executive Officer at BioCryst.

BioCryst has donated to the Department of Health and Human Services (HHS) an initial supply sufficient for 1,200 courses of i.v. peramivir 600 mg once-daily for five days.

This transfer of intravenous peramivir was made under the development contract with HHS to allow doctors and patients near-term access to the drug, and is separate from the RFP process.

BioCryst has worked with HHS to enable the Government to rapidly deploy an initial supply of peramivir, and the company is prepared to deliver more, said Jon P. Stonehouse.

BioCryst is completing production of approximately 130,000 courses of i.v. peramivir and is prepared to make more,anticipating peramivir orders that the company may receive from the U.S. or other governments during this pandemic emergency.

Peramivir 300 mg or 600 mg i.v. single and multiple doses were generally safe and well tolerated in these trials.

Peramivir is a good drug for severely ill flu patients as there is demand for intravenously administered drugs for such patients, experts said.

Currently, Roche Holding AG’s Tamiflu (oseltamivir) and GlaxoSmithKline Plc’s Relenza (zanamivir) are only available antivirals to  treat the pandemic H1N1 swine infection.

Shionogi, the maker of the Crestor cholesterol pill, is the first among three Japanese drugmakers to seek approval in Japan for flu treatments under development. Laninamivir from Daiichi Sankyo Co. and favipiravir from Fujifilm Holdings Corp.’s Toyama Chemical Co are the two ather antivirals currenly in development.

BioCryst Pharmaceuticals develops novel small-molecule pharmaceuticals that block key enzymes involved in infectious diseases, cancer and inflammatory diseases. BioCryst has progressed two novel compounds into late-stage pivotal clinical trials; peramivir, an anti-viral for influenza, and forodesine, a purine nucleoside phosphorylase (PNP) inhibitor forcutaneous T-cell lymphoma (CTCL).

BioCryst has strategic alliances with the U.S. Department of Health and Human Services, Shionogi & Co., Ltd., Green Cross Corporation and Mundipharma International Holdings Limited validate its scientific foundation and the utility of its product candidates.