Press release
European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) Recommends Approval of Tecovirimat
- Broader Indication to Include Smallpox, Monkeypox, Cowpox, and Vaccinia Complications - NEW YORK, Nov. 16, 2021 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc.
About this update from Siga Technologies Inc.
[{"type":"text","content":"- Broader Indication to Include Smallpox, Monkeypox, Cowpox, and Vaccinia Complications - NEW YORK, Nov. 16, 2021 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced that the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) published their summary opinion in support of approval of SIGA’s Marketing Authorisation Application (MAA) for oral tecovirimat. Oral tecovirimat is the same formulation that was approved by the U.S. Food and Drug Administration in July 2018 under the brand name TPOXX®. The recommendation from the CHMP, which plays a vital role in conducting the scientific assessment of MAAs, included support for broader labeling for oral tecovirimat indicating its use for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications. The MAA was filed under the centralized application process, which, upon approval, will enable sales and marketing of oral tecovirimat in all EU member states, as well as Norway, Iceland, and Liechtenstein. SIGA is targeting EMA approval for the first quarter of 2022. “We are grateful to the CHMP for their hard work and support of tecovirimat for approval with the EMA, which would enable maximum access to the product throughout Europe,” said Dr. Dennis Hruby, CSO of SIGA. “The ongoing COVID-19 pandemic has underscored the importance of preparedness, a component of which is governments around the world building robust stockpiles that will allow effective responses to infectious disease outbreaks such as smallpox, a significant bioterror threat that could be even more devastating than COVID-19. EMA approval is an important step in our international strategy for tecovirimat to be available in the European market.” In June 2019, SIGA entered into an international promotion agreement with Meridian Medical Technologies, Inc. (“Meridian”), a Pfizer company. Under the agreement, Meridian will promote the sale of oral tecovirimat for the treatment of smallpox in all international markets outside of the United States. SIGA will continue to own all rights to the product and its related intellectual property. SIGA also has an application pending for approval of oral tecovirimat with Health Canada. In 2020 and 2021, SIGA announced international sales with t...