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A Corvallis biotech firm is on a fast track toward approval of the world’s first treatment for smallpox.

Siga Technologies announced on Wednesday that the Food and Drug Administration has accepted its new drug application for the oral formulation of Tpoxx, the company’s pill for treating smallpox infection, and has promised to complete its review in six months rather than the usual 10.

The FDA has set a target date for final action of Aug. 8, the company said in a news release.

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.

While naturally occurring smallpox was eradicated by 1980 thanks to a worldwide vaccination campaign, research samples were kept by the U.S. and Soviet governments, leading to fears that the deadly virus could be synthesized or cloned for use as a biological weapon.

If the drug is approved by the FDA, Siga could begin marketing Tpoxx for commercial sale to foreign governments, major hospitals and large corporations concerned about bioterrorism, among other potential customers.

 

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Special Projects Editor

Special Projects Editor, Corvallis Gazette-Times and Albany Democrat-Herald

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