Posted by Michael Wonder on 13 Jul 2018
FDA approves the first drug with an indication for treatment of smallpox
13 July 2018 - The U.S. FDA today approved Tpoxx (tecovirimat), the first drug with an indication for treatment of smallpox.
Though the World Health Organisation declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that smallpox could be used as a bioweapon.
The FDA granted this application fast track and priority review designations. Tpoxx also received orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases and a Material Threat Medical Countermeasure Priority Review Voucher, which provides additional incentives for certain medical products intended to treat or prevent harm from specific chemical, biological, radiological and nuclear threats.
