SIGA Technologies Inc (SIGA), a commercial-stage pharmaceutical company, on Thursday, announced the regulatory approval of its antiviral drug, TEPOXX (tecovirimat 200 mg capsules), in Japan for the treatment of smallpox, mpox, cowpox, and complications following smallpox vaccination.
TEPOXX is the first antiviral approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for treating Orthopoxviruses, marking a significant milestone in global public health preparedness.
The approval follows SIGA's partnership with Japan Biotechno Pharma, the exclusive distributor in Japan, to supply TEPOXX for the country's national stockpile.
In October 2024, the Company announced its first sale of TPOXX (tecovirimat) in Africa, made in response to a request from the Ministry of Health in Morocco.
The approval is supported by a comprehensive data package, including results from 15 clinical trials involving over 800 healthy volunteers, and pivotal preclinical studies.
The clinical trials demonstrated no serious drug-related adverse events, while pharmacokinetic data confirmed that the drug remains effective within its therapeutic dose range.
Animal studies showed that TEPOXX significantly reduced mortality and viral load, particularly in non-human primates infected with the variola virus, which causes smallpox.
Commenting on the approval, Diem Nguyen, SIGA's CEO, said, "The approval of TEPOXX in Japan is a vital step in expanding access to this critical antiviral and enhancing global response to orthopoxvirus outbreaks. It approval highlights the importance of stockpiling antiviral treatments as part of global health security."
TEPOXX works by inhibiting the VP37 protein of Orthopoxviruses, preventing the virus from exiting infected cells, thereby slowing infection spread.
Tecovirimat, in capsule and injection formulation, is approved in the U.S. and Canada, under the brand name TPOXX for the treatment of smallpox. In the European Union and United Kingdom, it is marketed as Tecovirimat-SIGA for the treatment of smallpox, mpox, cowpox, and to treat complications following smallpox vaccination.
SIGA closed Tuesday's (Dec. 31, 2024) trading at $6.01, up 1.52%. In
premarket trading, the stock is up another 2.50% at $6.16.
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