July 17, 2018 Source: DrugDeliveryBusiness 232
A New York-based company named Siga Technologies has won FDA approval for its oral formulation of tecovirimat, used to treat smallpox, in case there occurs an outbreak.
This drug has the potential to reduce the impact of bioterrorism attacks. Siga Technologies further remarked that its request has been granted by the FDA for a priority review voucher, where an option is given to accelerate the FDA’s review of the future products.
The company announced that tecovirimat will be made available only through the U.S. government’s Strategic National Stockpile. Since the FDA approved tecovirimat with a shelf life of 7 years, Siga is entitled to a $50 million payment from BARDA (Biomedical Advanced Research and Development Authority).
The company declared that it would be receiving another $41 million under its current contract with BARDA once the agency approves that there is no significant difference between the approved drug and the one which has already been delivered to the Strategic National Stockpile.
Phil Gomez, the CEO of Saga Technologies said, “Tpoxx is proof that public-private partnerships work when the partners are committed to a focused mission; The FDA approval of Tpoxx achieves an important objective for both SIGA and our lead partner in the U.S. government, the Biomedical Advanced Research and Development Authority. The approval validates this novel smallpox therapy as an important medical countermeasure in response to a potential smallpox outbreak.”By Ddu
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