|BiorCryst’s Peramivir PDUFA Date Approaching|
|By Dr. Amna Sheikh|
|Tuesday, 11 November 2014 09:05|
As you may know, BioCryst Pharmaceuticals, Inc (NASDAQ:BCRX) submitted New Drug Application with U.S Food and Drug Administration (FDA) for approval of Peramivir in U.S. The same drug has already been approved in Korea and Japan for treatment of acute influenza. RNA viruses cause “the flu” or “influenza”. This virus relates to the known family of “Orthomyxoviridae” classified under influenza viruses. Previously, common antiviral drugs including neuraminidase inhibitors oseltamivir was used for treatment of influenza in United States of America. However, Peramivir is the first intravenous drug under consideration of FDA for treatment of influenza in U.S. It is one of the first and an important milestone achieved by BioCryst research team. According to the Chief Executive Officer and acting President of BioCryst, it is one of the biggest achievements in the history of their company and an exciting moment for them to submit Peramivir NDA with FDA to help patients in USA. The PDUFA date is December 23, 2014.
What is Peramivir?
Peramivir is a strong, intravenously managed new anti-viral mediator that quickly serves soaring plasma absorptions to the infected regions. The drug has been discovered, developed and produced by BioCryst and it slows down the exchanges of flu neuraminidase, a stimulant which is important to the increase or development of virus in the patient. The results and action of Peramivir has been tested in the laboratory against numerous influenza viruses including pandemic H1N1 and H7N9. It has shown good results against viral strains like swine flu. The overall cost for research and development of Peramivir has been approximated as under $234.8 million. The contract was financed by BARDA/HHS. Peramivir has been launched in Japan as RAPIACTA by Shionogi & Co. Ltd in January 2010. Moreover, Green Cross Corporation has got the marketing and manufacturing rights for intravenous Peramivir in the jurisdiction of Korea for treatment of patients suffering with avian influenza, H1N1 and other A & B viruses.
What is influenza?
The disease of influenza is commonly pronounced as “the flue”. It is an infectious disease found in mammals and birds. Patients suffering with influenza can observe some common symptoms as runny nose, chills, sore throat, fever, muscle pains, coughing, headache, fatigue/weakness and general discomfort. Sometimes, influenza produces vomiting and nausea especially in case of infants. Air is used as the career for influenza viruses by sneezes or cough. Moreover, direct contact with sufferer’s nasal secretions or bird droppings can also become a cause of influenza. In many cases, it can lead to bacterial pneumonia or viral pneumonia.
BioCryst Pharmaceuticals devises, develops and optimizes fresh minute molecule medicines that chunk major stimulants implicated in transferable and uncommon ailments, with the objective of dealing with unmet remedial requirements of physicians and patients. Currently, the company has defined its core development programs that are concentrated towards production of BCX4161 and development of two future generation oral determents of kallikrein plasma for traditional angioedema, BCX4430 and Peramivir. The company is determined to help and serve patients suffering with enduring infectious diseases through research and development.