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Factor VII

One of the most important product of AryoGen is Recombinant Activated Human blood coagulation Factor VII, with trade name AryoSeven. AryoSevenTM is indicated for treatment and prevention of bleeding episodes in patients with:
- Hemophilia A or B with inhibitors
- Acquired hemophilia
- Congenital factor VII deficiency
- Glanzmann’s thrombasthenia

AryoSevenTM 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 has been found highest imaginable similarity 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.
These clinical trials has done on patients with congenital factor VII deficiency clinical trial and results was totally comparable with branded name drug in increment in serum level of FVII, reducing bleeding events, reducing severity of bleeding and occurrence of adverse events.
Also, in clinical trial with Hemophilia patients with inhibitor clinical trial AryoSeven was totally comparable with branded drug based on Kavakli global response scoring system, bleeding episodes, increment in serum level of FVII and occurrence of adverse events.
AryoSevenTM, 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 highly purified to be acceptable as injectable human drug. This biosimilar medicine is produced under strict cGMP standards and is now used by several thousands of patients in different countries.
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