Sevenfact

Sevenfact (coagulation factor VIIa [recombinant]-jncw) is a medication to treat and control spontaneous bleeding episodes in people with hemophilia A or B with inhibitors, ages 12 and older.

The Laboratoire Francais du Fractionnement et des Biotechnologies (LFB) developed Sevenfact. It was approved by the  U.S. Food and Drug Administration (FDA) in April 2020. HEMA Biologics has marketing rights for Sevenfact in the U.S. and Canada.

How does Sevenfact work?

In people with hemophilia, the blood does not clot efficiently. This is either because the body cannot produce enough clotting factors, specialized proteins involved in blood clotting, or — as is the case in acquired hemophilia — it mistakenly attacks its own clotting factors.

Hemophilia type A patients have little or no clotting factor VIII, while hemophilia type B patients lack clotting factor IX.

Accidents or injuries can be more dangerous to people with this disease, because their blood does not clot properly. Patients can also start to bleed spontaneously.

Sevenfact is a type of bypassing agent. It allows the body to circumvent or bypass the lack of a clotting factor.

The active ingredient in Sevenfact is an artificial form of FVII. This compound is isolated from the milk of genetically engineered rabbits. It is converted into its activated form (FVIIa) through the use of LFB’s proprietary rPro technology.

Because Sevenfact is a treatment that scientists engineer in the laboratory, it can bypass the inhibitors — antibodies that perceive the induced clotting factor as a foreign threat — that some patients produce against the clotting factor concentrates they use as treatment. Inhibitors prevent the treatment from working as intended.

Sevenfact in clinical trials

A Phase 1 clinical trial (NCT01708564) assessed the safety and pharmacokinetics (movement in the body) of three escalating doses of Sevenfact in 15 patients with hemophilia A or B, with or without inhibitors. Researchers found the treatment safe and reported no serious side effects.

A Phase 3 clinical trial (NCT02020369), called PERSEPT 1, assessed the safety and efficacy of Sevenfact in controlling mild or moderate bleeding episodes in 27 adults or adolescents with hemophilia A or B with inhibitors. The treatment was administered into patients’ bloodstream at a dose of 75 or 225 mcg/kg. Over the course of the study, Sevenfact was used to control a total of 465 mild or moderate bleeds.

Trial results, published in the journal Haemophilia, demonstrated that the lower dose of Sevenfact was able to control 84.9% of mild-to-moderate bleeds within 12 hours. The higher dosage had a greater success rate, at 93.2%. Three patients experienced severe bleeding episodes during the trial, which the higher dose of Sevenfact successfully managed.

Patients tolerated Sevenfact well, with the most common side effects being headaches, fever, and dizziness.

Other information

Because Sevenfact is generated in rabbits, patients with an allergy to rabbits should not use the medication.

 

Last updated: April 6, 2020

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