Product Launches

Sobi introduces haemophilia A drug Elocta in Europe

Company Report

 Haemophilia A is a rare, chronic and genetic disorder in which there is protein factor VII lowers down and blood clotting is impaired, causing irreversible joint damage, pain and life-threatening haemorrhages. As per the World Federation of Hemophilia, approximately 140,000 people are living with haemophilia A globally.

Swedish Orphan Biovitrum AB (publ) (Sobi) has announced the commercial launch of Elocta (efmoroctocog alfa) in Europe. Elocta, first recombinant human clotting factor VIII Fc fusion protein that offers prolonged protection against bleeding associated with prophylactic injections every three to five days.

The commercialization and development of Elocta for haemophilia A are under collaborative partnership of Sobi with Biogen. The drug has already received approval for the treatment of haemophilia A in Canada, Australia, New Zealand, United States and Australia. 

The approval was on the basis of pivotal phase 3 clinical trial study in males with 12 years and older with severe haemophilia and also from kids under 12 years of age with haemophilia A. The drug has been indicated to use for all age groups for the indication of prophylaxis and haemophilia A treatment in European Union. Elocta offers prolonged protection against bleeding associated with prophylactic injections and the recommended dosage by SmPC is 50 IU/kg in every three to five days. The dosage varies from 25 to 65 IU/kg which depends upon the bleeding frequency, factor VIII deficiency, clinical condition and patient’s activity. Sobi has already received development and commercialization rights in North Africa, Russia, Europe and some Middle East countries.

Geoffrey McDonough, CEO and president at Sobi stated that The launch of Elocta is an important milestone for the haemophilia community, offering people with haemophilia A in the EU a treatment option that provides extended protection against bleeds. Since the approval of Elocta in the EU, our focus has been to ensure timely and sustainable access to Elocta for people living with haemophilia A. We are delighted to be able to announce that Elocta is now available."

According to Pharmaion, pharma and healthcare consultants, Elocta is recommended in patients with haemophilia A and development of this prophylactic treatment helps in reducing the progression of joint disease and overall improvement in quality of life. Moreover, the drug is a recombinant fusion protein derived from human cell line and does not involve any additional animal or human protein, thereby lowering the chanced of rejection, allergies or side effects.





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