Treatment for Blood disorders
Up to now, several hundreds of hematologists have prescribed AryoSeven™ for treatment
of several thousands of their patients.
AryoSeven™ is recombinant activated human blood coagulation factor VII, produced
by Aryogen Biopharma under cGMP and EU regulations. It is used for treatment of patients with coagulation
Factor VIII deficiency which has developed neutralizing antibodies
against Factor VIII and also for patients with factor VII deficiency.
AryoSeven™, Human activated recombinant blood coagulation factor VII (rFVIIa),
is a glycoprotein with 406 amino acids and molecular weight of about 50 KD, which is produced in
Baby Hamster Kidney cell line (BHK) via recombinant technology and is secreted as a single chain
zymogene into medium. Secreted crude Factor VII is then highly purified to be acceptable as injectable
human drug. During purification process, this single chain molecule changes into its double chain
activated form as serine protease.
FVII contains four separated domains: a gamma-carboxyglutamic acid domain in amino terminal,
two epidermal growth factor-like (EGF-like) domains and a serine protease domain.
As mentioned, transformation of this zymogene to activated enzyme is done during purification process.
As a result, rFVIIa contains two jointed peptide chains, a light chain of 152
amino acids and a heavy chain of 254 amino acids. These chains are attached with a disulfide bond.
Factor VII is a vitamin K-dependent gamma -carboxylated glycoprotein, which in its activated form,
FVIIa, activates FX to FXa and FIX to FIXa by limited proteolysis. FVIIa full enzymatic activity is appeared when is complex
to tissue factor (TF) in the presence of calcium ions. Gamma-carboxyglutamic acid groups in light chain are essential for FVII proteolytic activity.
This biosimilar medicine is produced under strict cGMP standards and is formulated totally similar to the original drug and also has similar characteristics and functions with the native human blood factor VII.
The product is actually the first biosimilar or biogeneric of the original drug with a totally approved similarity.
Recommended International Nonproprietary Name (INN)
Eptacog Alfa (Activated)
Blood-coagulation factor VII (Human clone λHVII2463 protein moiety)
Chemical Abstracts Service (CAS) registry number
Anatomical Therapeutic Chemical (ATC) code
>>AryoSeven™ clinical trials
AryoSeven™ has proven to be as safe and effective as branded activated human
recombinant blood coagulation factor VII. AryoSeven™ is fully characterized in molecular level
by us and or third parties including regulatory and other third party laboratories and highest
imaginable similarity has been found so that it is not distinguishable from branded drug in most of the characteristics.
Also several clinical trials has done and there was no significant difference
in baseline characteristics between two arms in each trial.
Randomized double blind multicenter clinical trials were performed on Iranian patients with congenital
factor VII deficiency and hemophilia with inhibitors. Patients were enrolled in two parallel arms, comparing AryoSeven™ with branded recombinant factor VIIa.
There was no significant difference in baseline characteristics between two arms in each trial.
- Results in congenital factor VII deficiency clinical trial showed that:
1. Both arms were comparable based on increment in serum level of FVII.
Calculation of p-values confirmed that the groups have shown no significant difference.
2. Bleeding events were reduced during treatment in both study arms equally
and no significant difference was observed.
3. Severity of bleedings was reduced during treatment in both study arms
equally and no significant difference was observed.
4. Occurrence of adverse events was similar in both arms.
- Results in Hemophilia patients with inhibitor clinical trial showed that:
1. Both arms were comparable based on Kavakli global response scoring system which is a
novel method for assessment of pain and range of motion in joints following administration of rFVIIa for treatment of bleeding episodes.
Calculation of p-values confirmed that both arms have shown no significant difference.
2. Both arms were comparable based on increment in serum level of FVII. Calculation of p-values
confirmed that the groups have shown no significant difference.
3. Occurrence of adverse events was similar in both arms.
AryoSeven™ is available as lyophilized powder (Cake) in 2 ml vials along with a vial of water for injection.
Each dose contains 1.2 mg of active protein which is equal to 60 thousands international unit of biological activity.
If you need more information on AryoSeven™ please contact our consulting team at
Aryogen office or go to its website www.aryoseven.com
for more detailed description.