On March 12, 2013 Biogen Idec announced that the company submitted a Biologics License Application (BLA) to the FDA for the marketing approval of recombinant factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A.
Last month CSL Behring announced that the US Food and Drug Administration (FDA) has approved an expansion of the indication for Corifact®, a human plasma-derived factor XIII (FXIII) concentrate, to include the peri-operative management of surgical bleeding in adult and pediatric patients with congenital FXIII deficiency.
A clinical trial last month showed that a once daily, all-oral drug combination to treat chronic hepatitis C infection (HCV)--Bristol-Myers Squibb’s daclatasvir (NS5A replication complex inhibitor) and Gilead’s sofosbuvir (nucleotide NS5B inhibitor), direct-acting viral agents--was effective in all patients.
In mid-April, Achillion Pharmaceuticals, Inc., initiated an international Phase 2 clinical trial evaluating its new drug ACH-3102, in combination with ribavirin and another one of its drugs, sovaprevir (ACH-1625), for the treatment of patients with chronic hepatitis C virus (HCV) infections, genotype 1.
Gilead Sciences, Inc., announced in late April the results from four Phase 3 clinical trials (called NEUTRINO, FISSION, POSITRON and FUSION) to evaluate sofosbuvir (nucleotide NS5B inhibitor), the company’s investigational once-daily pill-form therapy for the treatment of chronic hepatitis C virus (HCV) infection. Sofosbuvir, a direct-acting agent, works by interrupting the HCV life cycle by suppressing viral replication.
CSL Behring has announced another donation of factor product to the World Federation of Hemophilia (WFH) in connection with World Hemophilia Day on April 17. The therapies will be used to treat patients in developing countries and who have certain types of bleeding disorders. The donation supports WFH’s progress in improving the diagnosis and treatment of bleeding disorders through its Global Alliance for Progress (GAP) program. The company’s current donation includes product used to treat von Willebrand disease and hemophilia. The volume of product donated is approximately 1 million international units (IUs).
In early February, Biogen Idec and Swedish Orphan Biovitrum (Sobi) released data on two investigational therapies for hemophilia: recombinant factors VIII Fc fusion protein (rFVIIIFc) and recombinant factor IX Fc fusion protein (rFIXFc).
Last month, Gilead Sciences reported that it had met its goals in two late-stage hepatitis C virus (HCV) drug trials. The trials, called Fission and Neutrino, incorporated the experimental HCV drug sofosbuvir as part of a combination 12-week therapy in previously untreated patients with chronic HCV.