FDA Approves Sanofi’s Once-Weekly ALTUVIIIO™

Source: Sanofi Press Release

Sanofi announces that the U.S. Food and Drug Administration approved ALTUVIIIO™ [Antihemophilic Factor (Recombinant), Fc-vWF-XTEN Fusion Protein-ehtl], previously known as efanesoctocog alfa, a first-in-class, high-sustained factor VIII replacement therapy for adults and children with hemophilia A. 

Sanofi states that with ALTUVIIIO, they are looking to raise the bar for people with hemophilia A and empower them to strive for a reality where their factor activity levels remain in the normal to near-normal range (over 40%) for most of the week.

Sanofi told HFA, “Based on our long-standing commitment to the hemophilia community, we understood there were ongoing, unmet needs for therapy that could reduce treatment burden while delivering the bleed protection patients need. This insight drove our scientists to develop a new treatment that could help address some of these challenges for people with hemophilia A.”

Sanofi also underscored their ongoing commitment to support the hemophilia community, and stated, “This wouldn’t have been possible without support from organizations like HFA and the willingness of people living with hemophilia and their families who are involved in our clinical trials.”

U.S. INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATION
ALTUVIIIO™ [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is an injectable medicine that is used to control and reduce the number of bleeding episodes in people with hemophilia A (congenital Factor VIII deficiency).

Your healthcare provider may give you ALTUVIIIO when you have surgery.

IMPORTANT SAFETY INFORMATION

What is the most important information I need to know about ALTUVIIIO?

Do not attempt to give yourself an injection unless you have been taught how by your healthcare provider or hemophilia center. You must carefully follow your healthcare provider’s instructions regarding the dose and schedule for injecting ALTUVIIIO so that your treatment will work best for you.

Who should not use ALTUVIIIO?

You should not use ALTUVIIIO if you have had an allergic reaction to it in the past.

What should I tell my healthcare provider before using ALTUVIIIO?

Tell your healthcare provider if you have had any medical problems, take any medications, including prescription and non-prescription medicines, supplements, or herbal medicines, are breastfeeding, or are pregnant or planning to become pregnant.

What are the possible side effects of ALTUVIIIO?

You can have an allergic reaction to ALTUVIIIO. Call your healthcare provider or emergency department right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash, or hives.

Your body can also make antibodies called “inhibitors” against ALTUVIIIO. This can stop ALTUVIIIO from working properly. Your healthcare provider may give you blood tests to check for inhibitors.

The common side effects of ALTUVIIIO are headache, joint pain, and back pain.

These are not the only possible side effects of ALTUVIIIO. Tell your healthcare provider about any side effect that bothers you or does not go away.

Please see full Prescribing Information.