SFL marketing authorization application for the orphan medicinal product “Obiltoxaximab SFL” receives CHMP positive option
On 17 September 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization under exceptional circumstances for the orphan medicinal product Obiltoxaximab SFL. The European Commission final decision (marketing authorization) is expected in November 2020.
SFL Pharmaceuticals Deutschland GmbH filed the marketing authorization application (MAA) and will act as future marketing authorization holder (MAH) in EU on behalf of Elusys Therapeutics Inc, the originator of the product.
Obiltoxaximab SFL (obiltoxaximab) is indicated in all age groups:
- In combination with appropriate antibacterial drugs for treatment of inhalational anthrax due to Bacillus anthracis.
- For post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available.
“I would like to thank our partner Elusys Therapeutics Inc. for the trust to manage the entire MAA filing on their behalf. I would like to thank SFL multi-disciplinary team for their excellent support to achieve this important milestone” said Shayesteh Fürst-Ladani CEO of SFL group of companies.
“I would like to thank the SFL team for providing comprehensive support for all steps of the EU filing and approval process from orphan drug designation (ODD), through to MAA filing and review, as well as acting as future MAH on behalf of Elusys in the EU. The cooperation between the Elusys and SFL team has been excellent and we are pleased to have achieved this important milestone.”, said Elizabeth Posillico, President and CEO of Elusys.
SFL group of companies provide premium support to pharmaceutical and medtech companies.
SFL Regulatory Affairs & Scientific Communication GmbH offers comprehensive multi-disciplinary support in Regulatory Affairs, Medical Affairs, Public Affairs, Quality Assurance, Pharmacovigilance, Compliance, Reimbursement and Supply Chain.
SFL Pharmaceuticals Deutschland GmbH takes representative roles acting as MAA applicant and MAH on behalf of our clients in EU.
SFL Pharma GmbH takes representative roles acting as MAA applicant and MAH on behalf of our clients in Switzerland.
For more information, please visit www.sfl-services.com.
About Elusys Therapeutics, Inc.
Elusys Therapeutics, a private company based in Parsippany, NJ, is focused on the development of antibody therapeutics for the treatment of infectious disease. In March 2016, the U.S. Food and Drug Administration (FDA) approved ANTHIM (obiltoxaximab) Injection (www.anthim.com), the company’s monoclonal antibody (mAb) anthrax antitoxin, for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. In July 2020, Anthim (obiltoxaximab for injection) received Health Canada approval for use in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs; and for post-exposure prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or not appropriate (www.elusysproducts.com).
Elusys has received over $240M in development grants and contracts from the U.S. Department of Defense (DoD), National Institutes of Health (NIH) and BARDA. Current investors include EW Healthcare Partners, Invesco Private Capital, Crescendo Ventures, MedImmune Ventures and Pfizer. For more information, visit www.elusys.com.
|Contact for SFL
CEO of SFL Companies
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|Contact for Elusys Therapeutics Inc.
VP Corporate Development, Elusys