Pfizer launches new BeneFIX® room temperature storage packs for haemophilia B in Europe

Following approval by the European Commission, Pfizer announced today the launch of BeneFIX® with Room Temperature Storage (RTS). BeneFIX® RTS can now be stored for up to two years at room temperature (2-30°C)1 offering greater freedom and flexibility for haemophilia B patients. This storage extension will increase patient convenience and builds on the significant improvements to the BeneFIX® preparation process.2

BeneFIX® is the first and only recombinant factor IX (rFIX) product licensed for the treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency)1. Patients, many of whom have to infuse multiple times each week, will consequently be freed from the constraint of needing to refrigerate their medication, allowing for greater flexibility to carry out daily activities. Furthermore, the cost and inconvenience of cold storage is negated for pharmacists, healthcare professionals and medical suppliers.

Since its launch in 1997 BeneFIX®has remained the product of choice in the treatment of haemophilia B as it offers patients access to a product that is inherently free from the risk of transmission of human blood-borne pathogens3. Nonetheless, Pfizer is constantly seeking innovative new strategies to help improve the patient experience and offer a more convenient treatment that is simpler to store, prepare and administer. Patient convenience is an unremitting priority in haemophilia care, particularly in simplifying the reconstitution of the drug and minimising the infusion time through more concentrated recombinant FIX protein preparations and smaller infusion volumes for higher dosing strengths.2

Commenting on the longstanding success of BeneFIX® Cees Heiman, Regional President Europe said: “BeneFIX®offers an established efficacy and safety profile. The treatment has transformed the outlook for haemophilia B patients over a decade ago; it is used and trusted by healthcare professionals and patients today, and remains the treatment of choice. Pfizer’s development of the new BeneFIX®RTS demonstrates the commitment to constantly strive and maintain the best and most efficient options for patients, especially those who suffer with a lifelong condition such as haemophilia B.”

Studies show that BeneFIX® is consistent in its treatment and prophylaxis of bleeding in patients with haemophilia B with 91% of previously treated patients and 91-94% of previously untreated patients having an ‘excellent’ or ‘good’ response to BeneFIX®according to participants/ investigators.4,5

About haemophilia

Haemophilia B is a rare, inherited coagulation disorder. People with haemophilia are deficient in one of the key proteins — either factor VIII (haemophilia A) or factor IX (haemophilia B) — that are vital in the clotting cascade to prevent bleeding. In severely affected patients, both forms of haemophilia are characterised by spontaneous haemorrhages or prolonged bleeding, typically into joints and soft tissue. Patients with haemophilia B are dependent on protein replacement therapy with factor IX.

About BeneFIX®

BeneFIX® is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).

Important Safety Information

* As with the intravenous administration of any protein product, common adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, or tiredness.

* BeneFIX® may be contraindicated in patients with a known history of hypersensitivity to hamster protein.

* Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported for all factor IX products. Patients should be informed of the early symptoms and signs of hypersensitivity reactions. Patients should discontinue use of the product and contact their health care provider immediately and/or seek emergency care if any hypersensitivity reactions occur.

Please see full Prescribing Information at: http://www.hemophiliavillage.com.

References

1. BeneFIX®SPC
2. Lambert T, Recht M, Valentino LA et al. Reformulated BeneFIX: efficacy and safety in previously treated patients with moderately sever to sever haemophilia B. Haemophilia 2007, 13, 233-243
3. Adamson S, Charlebois T, O’Connell B et al. Viral safety of recombinant Factor IX. Semin Hematol 1998; 35 (Suppl 2): 22–27.
4. Roth DA, Kessler CM, Pasi KJ et al. Human recombinant factor IX: safety and efficacy studies in hemophilia B patients previously treated with plasma-derived factor IX concentrates. Blood 2001; 98: 3600–3606.
5. Shapiro AD, Di Paola J, Cohen A et al. The safety and efficacy of recombinant human blood coagulation factor IX in previously untreated patients with severe or moderately severe hemophilia B. Blood 2005; 105: 518–525.