FDA agrees to expedite review of new Smallpox Treatment
Siga Technologies have received the good news that the FDA has greed to expedite its review of their new Smallpox treatment TPOXX®. FDA reviews usually take 10 months but in this instance they have agreed to complete the review of TPOXX® in only 6 months.Laboratory and animal tests suggest that SIGA’s investigational countermeasure TPOXX® (USAN tecovirimat, ST-246®)*, blocks the ability of the virus to spread, thus preventing disease symptoms in animal models of smallpox in which TPOXX has been tested to date. Siga, which is headquartered in New York and maintains research laboratories in Corvallis, has already delivered 2 million courses of its smallpox treatment to the Strategic National Stockpile under a $433 million contract with the U.S. Biomedical Advanced Research and Development Authority.
Tpoxx, also known as tecovirimat and ST-246, was developed under the FDA’s streamlined “animal rule,” which was created to address potential terrorist threats after the 9/11 attacks. The rule allows testing on animals to determine efficacy and human clinical trials to determine safety and confirm dosage levels.
Now, because there is still no approved treatment for smallpox, Siga is seeking expedited FDA review of its new drug application. The company claims there were no drug-related serious adverse events during human testing.