Shire plc announced the launch of Advate (Octocog alfa - Recombinant Coagulation Factor VIII) in India for the treatment and prophylaxis of bleeding in patients with haemophilia A. Advate, which came to Shire as part of the recent Baxalta combination, was approved in the US since July 2003 and has a proven safety and efficacy profile with over 13 years of real-world patient experience data.

It is the world's most widely used FVIII treatment to date, according to a company release.

“Shire has been part of the haemophilia community for over 60 years. We are committed to the advancement of haemophilia treatments and elevating the standard of care for haemophilia patients in India because we know that many of them out there are not diagnosed, let alone treated. Striving toward a goal of zero bleeds, we are able to bring innovative third generation treatments like Advate to patients in India and help them achieve better outcomes in managing their bleeding conditions,” said Vineet Singhal, country head, Baxalta Biosciences India Pvt. Ltd.

Advate is the world’s first third generation recombinant factor VIII – a full-length molecule that uses the complete gene, similar to the factor VIII that occurs naturally in the body, and was first of its kind to be developed without the addition of any human or animal-derived protein in the cell culture process, purification or final formulation. The treatment of this rare genetic bleeding disease, haemophilia, also greatly reduce the risk of transmission of blood-borne pathogens, and relies on clotting factors concentrates of high quality.

Clotting factor concentrates can be made in two different ways: Plasma-derived clotting factors - prepared from the plasma of donated human blood;

Recombinant clotting factors - the first generation of recombinant products use animal products in the culture medium and had human albumin (a human blood product) added as a stabilizer. Second generation products use animal-derived materials in the culture medium but do not have added albumin and instead, use sucrose or other non-human derived material as a stabilizer. Third generation products are produced without the addition of any human or animal-derived protein in the cell culture process, purification or final formulation.

With the introduction of the third generation clotting factors which have no albumin present at any stage of their preparation, patients in India now have access to a safer and more reliable therapy option. Advate has a 24 months shelf life and allows 6 months storage at room temperature within this shelf life period. In addition, Advate has been clinically shown to reduce the number of bleeding episodes in adults and children (0-16 years) for up to 98 per cent when used regularly (prophylaxis).

Haemophilia A is a challenging chronic disease affecting 1 in 10.000 male births with no difference in geography and races. If untreated, people with haemophilia will suffer from recurrent bleeding causing pains which lead to disability and even young death. Today, The World Federation of Hemophilia estimates that the disease affects more than 400,000 people worldwide, with an estimated 75 percent of them being undiagnosed and untreated or undertreated globally.

According to the Hemophilia Federation of India, only 16,000 or 15 per cent of the total haemophilia population has been currently identified in India and the rest lay undiagnosed – which could be ranging 7 times more than the current registered patients. For people with haemophilia, reducing their bleeding episodes (measured by annual bleed rate (ABR)) may have a significant improvement on long-term outcomes and quality of life.