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Nuwiq

Nuwiq^® (simoctocog alfa; antihemophilic factor [recombinant]) is a recombinant factor VIII (FVIII) initially approved in the United States in 2015. It is indicated for the on-demand treatment, routine prophylaxis, and perioperative management of bleeding in adults and children with hemophilia A. Unlike other recombinant FVIII products, Nuwiq is produced from human embryonic kidney (HEK) 293F cells. No human or animal derivatives are used in the manufacturing process or added to the final product after translation. Nuwiq is developed and manufactured by Octapharma.¹

Hemophilia A and Its Impact

Hemophilia A is a bleeding disorder characterized by a lack of the clotting protein, coagulation FVIII. It causes a delayed clotting time, which leads to blood loss during injuries. Patients with hemophilia A bleed for longer periods of time than normal individuals. The amount of FVIII in the plasma affects the frequency and severity of bleeding. Hemophilia A affects about 20,000 persons in the United States, according to the Centers for Disease Control and Prevention (CDC).²

Mechanism of Action of Nuwiq

B-domain deleted recombinant coagulation factor VIII (BDD-rFVIII) is the active ingredient in Nuwiq that temporarily substitutes the missing B-domain, present in the full-length plasma-derived FVIII and facilitates necessary hemostasis.^1,2 The medicine is formulated as a white, sterile, nonpyrogenic lyophilized powder that is reconstituted in single-use vials. Nuwiq is the only recombinant FVIII with the lowest diluent volume (2.5 mL).²

Get full prescribing information on Nuwiq at MPR

Efficacy in Trials and Trial Results

Three prospective, open-label clinical investigations in previously treated patients with severe hemophilia A were performed. A total of 135 patients with hemophilia A were managed with Nuwiq across all clinical investigations, including 74 adults, 3 adolescents between the ages of 12 and 17 years, and 58 children between the ages of 2 and 11 years. A total of 16,134 infusions of Nuwiq were administered over 15,950 exposure days. The overall prophylactic efficacy of Nuwiq for spontaneous bleeding was evaluated as excellent or good in 92% of participants in a trial of 32 adults. The prophylactic efficacy for spontaneous bleeding was evaluated as excellent or good in 97% of patients in a trial of 59 children. During prophylaxis, the mean annualized bleeding rates (ABR) for spontaneous bleeds were 1.5 in children and 1.2 in adults. The ABRs for hemophilia A patients receiving Nuwiq prophylaxis were lowered by 96% in adults and 93% in children when compared to on-demand treatment. In adults, 30 of 30 (100%) breakthrough bleeds were treated as excellent or good with Nuwiq prophylaxis, whereas in children, 89 of 108 (82%) bleeds were treated as excellent or good. In a study of 20 adults and 2 adolescents treated on-demand with Nuwiq, the effectiveness of the treatment was excellent or good in 931 of 986 (94%) bleeds. The overall surgical prophylactic efficacy of Nuwiq was graded as excellent or good in 32 of 33 (97%) surgeries.^1,3,4

Warnings, Precautions, and Adverse reactions

Hypersensitivity reactions, including anaphylaxis, can be seen with Nuwiq. Angioedema, chest tightness, difficulty breathing, urticaria, wheezing, and itching are early indications of hypersensitivity reactions that might escalate to anaphylaxis. If hypersensitivity responses occur, the medication should be stopped immediately and medical attention should be sought.⁵

Nuwiq use may cause neutralizing antibodies (inhibitors) to develop. If bleeding is not managed with the appropriate dose or if the expected plasma FVIII activity levels are not achieved, an assay should be performed to determine the FVIII inhibitor concentration.⁵

The most common adverse reactions, seen in more than 5% of cases during clinical trials, include headache, fever, chills, cough, upper and lower respiratory tract infection, rhinitis, abdominal pain, anemia, arthralgia, and pharyngitis.¹No drug-drug interaction studies have been conducted on Nuwiq.⁶

References

Nuwiq. Prescribing information. Octapharma; 2020. Accessed December 29, 2021.
Nuwiq, anti-haemophilic factor (recombinant) for the treatment of haemophilia A. Clinical Trials Arena. Accessed December 29, 2021.
Nuwiq. Package insert. Octapharma; 2015. Accessed December 29, 2021.
Nuwiq (recombinant factor VIII). CenterWatch. Accessed December 29, 2021.
Nuwiq®️ – efficacy. Octapharma USA Inc. Accessed December 29, 2021.
Nuwiq, INN-simoctocog alfa. European Medicines Agency. Accessed December 29, 2021.

Reviewed by Debjyoti Talukdar, MD, on 1/31/2022.

Harshi Dhingra, MD

Harshi Dhingra is a licensed medical doctor with specialization in Pathology. She is currently employed as faculty in a medical school with a tertiary care hospital and research center in India. Dr. Dhingra has over a decade of experience in diagnostic, clinical, research, and teaching work, and has written several publications and citations in indexed peer reviewed journals. She holds medical degrees for MBBS and an MD in Pathology.

Hemophilia