China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced the filing of a Drug Master File (DMF) with the US Food and Drug Administration (FDA) for its tecovirimat active pharmaceutical ingredients (APIs). This move signifies the company’s initiative to bring a potential treatment for poxvirus infections, including smallpox and monkeypox, to the global market.
Tecovirimat’s Mechanism of Action and Designation
Tecovirimat is a small-molecule broad-spectrum membrane protein inhibitor that targets the VP37 protein of the orthopoxvirus. It prevents the formation of a virus-specific envelope complex, inhibiting the output of infectious envelope viral particles and, consequently, the intercellular and remote transmission of the virus. Originally developed by Siga Technologies, tecovirimat was granted Orphan Drug Designation (ODD) status in the US in 2010 for the treatment of poxvirus infection.
Market Approvals and Usage
Tecovirimat became the first drug approved to treat smallpox and was later approved in the European Union (EU) for use in smallpox, monkeypox, cowpox, and complications following smallpox vaccination. It has been used off-label to treat monkeypox in the US since last year. In China, monkeypox was recently categorized as a category B infectious disease, and no product has been approved for marketing to address it.-Fineline Info & Tech
