Korea FDA Allows Emergency Use Of Intravenous Peramivir for Seriously Ill A/H1N1 Patients
This article was originally published in PharmAsia News
Executive Summary
SEOUL - For the first time in its fight against A/H1N1, the Korea Food & Drug Administration allowed the use of injectable antiviral peramivir in a seriously-ill patient even though the product is not yet approved in South Korea
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SEOUL - For the first time in its fight against A/H1N1, the Korea Food & Drug Administration allowed the use of injectable antiviral peramivir in a seriously-ill patient even though the product is not yet approved in South Korea. Developed by BioCryst Pharmaceuticals for treatment of influenza, Green Cross produces the drug in Korea. The first person to receive the injectable antiviral was a 72-year-ol man treated in a hospital emergency room in Seoul Nov. 25. The man had breathing complications associated with the H1N1 virus and was on a respirator, Lee Do-Han, a KFDA spokesman told PharmAsia News. "It is the first supply of such a treatment for an A/H1N1 patient before the release of our approval for market sales," he said. Partnered with BioCryst Pharmaceuticals and Shionogi Pharmaceuticals, vaccine producer Green Cross has been gearing up to launch its version of peramivir for desperately-ill flu patients even before the KFDA approval (Also see "Korea's Green Cross Seeks To Unveil Injectable Flu Antiviral Peramivir Even Before KFDA Approval" - Scrip, 12 Nov, 2009.) Green Cross plans on submitting its official approval request to KFDA by the end of December, Green Cross spokeswoman Han Jung-A told PharmAsia News. "Until when we receive the KFDA approval, we may have to provide peramivir to other emergency patients on a case-by-case request from their doctors." H1N1 Pandemic Likely Peaked In October - Health Officials The supply of peramivir comes at a time when Korean government officials announced that the H1N1 flu pandemic may have passed its peak. The country's H1N1 death toll stands at 104 people so far. That number is lower than expected due to ongoing nationwide vaccinations for students and others classified as more vulnerable to the disease. Health officials said the spread of the virus will likely lose momentum as more people are vaccinated. Students will also be better protected next month as schools enter winter vacations, they said. Earlier in October, Shionogi filed a new drug application for peramivir with Japan's Ministry of Health, Labor and Welfare. The early NDA submission came just three months after the Osaka-based company completed a Phase III study for the drug (PharmAsia News, Nov. 6, 2009). The development of peramivir was supported by the U.S. Department of Health and Human Services as part of the U.S. government's effort to prepare against the threat of an influenza pandemic. On Oct. 23, U.S. FDA issued an Emergency Use Authorization for peramivir, allowing the use of the drug in intravenous form for hospitalized patients only when "other available methods of treatment are ineffective or unavailable." Although the Korean government has secured adequate stockpiles of Roche's Tamiflu (oseltamivir) and GlaxoSmithKline's Relenza (zanamivir), they said the government may allow use of peramivir - the only intravenous option for treating A/H1N1 virus - if Tamiflu resistance develops and patients are unable to take Relenza via the inhaled route. - Peter Chang ([email protected]) |