SFL receives EU Commission approval for the orphan medicinal product “Obiltoxaximab SFL”
On 18 November 2020, the European Commission granted Marketing Authorization for Obiltoxaximab SFL. The approval comes after the Committee for Medicinal Products for Human Use (CHMP) had recommended on 17 September 2020 the granting of Marketing Authorization under exceptional circumstances for the orphan medicinal product Obiltoxaximab SFL.
SFL Pharmaceuticals Deutschland GmbH acts as Marketing Authorization Holder (MAH) in EU on behalf of Elusys Therapeutics Inc, the originator of the product.
“Obtaining EU marketing authorization is an important milestone to enable making Obiltoxaximab SFL available for treatment of inhalation anthrax. This was possible due to excellent cooperation between Elusys and SFL teams” said Shayesteh Fürst-Ladani CEO of SFL group of companies.
SFL group of companies provide premium support to pharmaceutical and medtech companies.
SFL multi-disciplinary team offers support across all life cycle stages from development to registration and post-marketing activities.
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.