The prophylaxis treatment is named Adynovate and is an innovative extended half-life recombinant Factor VIII (rFVIII) treatment, using established technology (controlled PEGylation), for hemophilia A patients.
Adynovate in combination with MYPKFIT, is the first and only FDA approved application that offers personalized and interactive prophylaxis treatment
option that enables both healthcare professionals (HCPs) and patients in real-time monitoring, the company said in a statement.
Alerts are sent to patients on prophylaxis when their estimated factor VIII levels are low, and reminds them 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 Indian regulatory bodies such as the DCGI, and the CDSCO.
“Individuals with severe hemophilia have recurrent hemarthrosis – fragmentation of joint cartilage, bone destruction, and crippling, which can be effectively reduced through prophylaxis as opposed to on-demand therapy,” Dr. Sandeep Arora, Head of Medical Affairs and Patient Services, Takeda India, in a statement.
Adynovate has demonstrated “favorable safety and efficacy results that offer effective bleed resolution, better joint health, and almost zero spontaneous bleeds in majority”, he added.
Source: IANS
