Takeda launches Adynovate, a hemophilia drug in India

INDIA – Takeda Pharmaceutical Company Limited has launched Adynovate, an extended half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A patients in India.

Adynovate is a novel extended half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A patients that employs proven technology.

According to the company, it provides effective bleed resolution with close-to-zero spontaneous bleed in the majority of cases, improves joint health, and reduces infusion frequency and associated pain.

Hemophilia A, an uncommon inherited bleeding disorder is caused by mutations in the F8 gene, which provides instructions to produce the coagulation protein factor VIII.

The worldwide incidence of hemophilia A is approximately 1 case per 5000 males, with approximately one third of affected individuals not having a family history of the disorder.


The prevalence of hemophilia A varies with the reporting country, with a range of 5.4-14.5 cases per 100,000 males.

In India, it is estimated that more than 136,000 people have been diagnosed with the disorder that causes lifelong bleeding and has so far, has no known cure.

However, gene therapy presents a silver lining to people having hemophilia. Gene therapy has the potential to be a long-term therapeutic approach, or even a cure, for hemophilia as per Medscape, a website dedicated to providing access to medical information.

This can be achieved by delivering a healthy version of the F8 gene to liver cells, the body’s main producers of blood clotting factors.

Adynovate will help toward filling gaps in hemophilia treatment and assisting healthcare professionals and patients in better managing the condition, redefining options for hemophilia patients in India.

The use of prophylaxis by hemophilia patients to prevent bleeding increased from about one-third of patients according to a study reported by the US Centers for Disease Control.

Takeda claims that Adynovate, in conjunction with MYPKFIT, an FDA-approved application, provides a personalized and interactive prophylaxis treatment option that allows both healthcare professionals and patients to monitor factor VIII levels in real time on smartphones.

The personalized treatment option allows patients to adjust their activity decisions accordingly and improve their quality of life.

Alerts are sent to patients on prophylaxis when their estimated factor VIII levels are low, as well as reminders when their infusions are due, thereby providing excellent prophylactic coverage.

The drug is available in India post all necessary clinical trials, the company said, adding it has also taken requisite approvals including from India regulatory bodies such as Drugs Controller General of India (DCGI), and the Central Drugs Standard Control Organization (CDSCO).

Takeda India is part of Takeda Pharma’s group of companies headquartered in Japan. The company focusses on hematology, genetic diseases, immunology and gastrointestinal portfolios in the country.

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