Takeda Further Enables Hemophilia A Personalized Care With Launch of myPKFiT® Software for ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated]
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") today announced the U.S. availability of myPKFiT® for ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated], a web-based software and mobile application that is the first and only pharmacokinetic (PK)-dosing software approved by the U.S. Food and Drug Administration (FDA) for hemophilia A patients 12 and older and weighing at least 29 kg treated with ADYNOVATE.1
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Sample PK Profile on the myPKFiT for ADYNOVATE HCP software. 2 (Photo: Business Wire)
The myPKFiT for ADYNOVATE software leverages a streamlined approach to estimating PK curves, a key measure for assessing drug exposure over time. 2,3 With this software, healthcare professionals (HCPs) can estimate a full PK curve with as few as two measurable blood samples, compared to 9 to 11 as recommended by guidelines from the International Society on Thrombosis and Haemostasis (ISTH). 2,4 HCPs can then create a visual depiction of the PK curve using this patient information and sample data. 2
"More than ever, hemophilia management is driven by personalization, as we attempt to take a customized approach to care for each individual patient," said Dr. Cindy Leissinger, Professor and Director of the Louisiana Center for Bleeding and Clotting Disorders at Tulane University. "It's important for healthcare professionals and patients to have access to treatment options that help them manage care and prevent bleeding. With the FDA approval of myPKFiT for ADYNOVATE, patients will have another option available to them as they work closely with their healthcare professional to tailor their treatment regimen to their needs."
The myPKFiT for ADYNOVATE software for HCPs is accompanied by a patient app for Apple (News - Alert) and Android smartphone devices that allows users to log and track bleeds and infusions while also estimating their current level of factor VIII (FVIII), allowing them to structure their lifestyle and activities to align with their relevant level of FVIII coverage. 2,5
"myPKFiT for ADYNOVATE underscores our commitment to delivering personalized approaches to help manage hemophilia A," said Michael Denne, Vice President of U.S. Medical, Hematology and Rare Disease at Takeda. "The ability to adjust activity and lifestyle decisions based on estimated FVIII coverage is a step toward educating patients so their treatment can be personalized to their needs. That, for us, is the goal for PK-focused dosing to allow people to get the most out of their treatment regimen."
myPKFiT for ADYNOVATE was granted approval by the FDA in January 2020.1 Similarly, the FDA granted approval to myPKFiT for ADVATE® [Antihemophilic Factor (Recombinant)], a web-based software that aids healthcare professionals in personalizing a patient's prophylaxis dose and schedule of ADVATE, in 2017 and the patient application became available in August 2018.6
myPKFiT is Rx only. For safe and proper use of the software and mobile app, please refer to the complete instructions for use in the respective User Manuals.
myPKFiT for ADVATE [Antihemophilic Factor (Recombinant)] and ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] Intended Use
ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] and ADVATE [Antihemophilic Factor (Recombinant)] Important Information
Indications and Limitation of Use
ADYNOVATE and ADVATE are not indicated for the treatment of von Willebrand disease.
DETAILED IMPORTANT RISK INFORMATION
WARNINGS & PRECAUTIONS
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
About Hemophilia A
About Takeda Hematology
About Takeda Pharmaceutical Company
For more information, visit https://www.takeda.com.
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, "Takeda" is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words "we", "us" and "our" are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.