16 Jan 2019
Ergomed Congratulates Octapharma on Gaining Marketing Authorisation for Fibryga® in Switzerland

Ergomed and Octapharma have completed one of the key studies leading to a new product’s marketing authorisation in Switzerland. Ergomed is very proud to have been involved in conducting the FORMA-05 study in acquired fibrinogen deficiency, with the approval being great news for physicians and patients alike.

“The outstanding result of the clinical trials in congenital and acquired fibrinogen deficiency and the approval by Swissmedic represent great milestones for the company (Octapharma), as well as for the treating physicians, but most of all for patients suffering from critical bleeding,” Olaf Walter, Octapharma Board Member comments.

Ergomed CEO Stephen Stamp says “Ergomed is delighted to have partnered with Octapharma on helping get Fibryga® to approval by gathering the much needed controlled clinical evidence in acquired fibrinogen deficiency”.

Fibryga® has been approved for use in treating congenital and acquired fibrinogen deficiencies. Fibrinogen plays an important role in the coagulation system and is important for the initiation and propagation of building a firm blood clot. In addition to rare congenital fibrinogen deficiencies, there are significant numbers of patients with bleeding complications in surgeries and trauma caused by acquired low levels of fibrinogen.