Takeda to discontinue Hemofil M, Recombinate for hemophilia A
Sale of these older FVIII replacement therapies to end globally by mid-2026
Takeda Pharmaceuticals has decided to discontinue Hemofil M (human antihemophilic factor) and Recombinate (recombinant antihemophilic factor), both of which are approved as replacement therapies to prevent and control bleeding episodes in children and adults with hemophilia A.
“This was not a decision we made lightly,” Anthea Cherednichenko, Takeda’s vice president and franchise head of U.S. hematology, wrote in a letter informing patients of the company’s decision to discontinue the two products globally.
The decision was made because patients are switching to newer treatments — including Takeda’s own options — and not due to quality concerns, according to the company. Both Hemofil M and Recombinate remain safe and effective as described in their prescribing labels, per Takeda.
“As the treatment landscape evolves, we decided to discontinue these medicines as hemophilia patients continue to transition to alternate treatment options in the space, including those within our own hematology portfolio,” Cherednichenko wrote, adding to patients, “we understand that this directly impacts you.”
Hemofil M and Recombinate will be supplied until stocks run out or expire by mid-2026, depending on how many patients are still using them before switching to alternative treatments, according to the company. This was also noted in a statement from the National Bleeding Disorders Foundation, a U.S. nonprofit advocating for patients with bleeding diseases.
The foundation encouraged all people with hemophilia to register for the patient notification system, a communication system providing information on withdrawals or recalls for therapies for bleeding disorders.
Patients can switch to Takeda’s Advate, Adynovate, among other options
To help with the switch, Takeda advises patients to talk with their doctors about other treatment options. Two potential alternatives include the company’s Advate (octocog alfa) and Adynovate (rurioctocog alfa pegol), marketed as Adynovi in Europe.
“We encourage you to consult with your healthcare team now to allow time to develop longer-term plans,” the company wrote on a website it developed to answer to some frequently asked questions and support patients in their journey off Hemofil M or Recombinate. The site notes that, as of July 2022, Advate “the most widely used FVIII [replacement therapy] in the U.S.”
Hemophilia A is caused by the lack or dysfunction of factor VIII, or FVIII, a clotting protein also known as antihemophilic factor. Without FVIII, the blood cannot clot properly. As a result, people with hemophilia A may experience heavy and longer than usual bleeding episodes, occurring either spontaneously or as a result of an injury or surgery.
Both Hemofil M and Recombinate contain a FVIII concentrate that can be used as a replacement therapy to make up for the faulty or missing clotting protein. The therapies thus help to prevent and control bleeding in hemophilia A patients. Hemofil M is pooled from human plasma, while Recombinate contains a recombinant or lab-made version of FVIII.
We are proud to offer alternative treatment options … that may meet your individual needs and are similar to Hemofil M and Recombinate.
Like Recombinate, the company’s Advate and Adynovate therapies contain a recombinant version of FVIII that works in the same way as the clotting protein found naturally in the blood. Both are approved for routine prophylaxis, or preventive treatment, and for on-demand treatment of bleeding in children and adults with hemophilia A.
While both potential alternatives are given as an infusion directly into the bloodstream, in Adynovate, the recombinant protein is attached to polyethylene glycol, a molecule that makes it last longer in the blood. As a result, Adynovate requires fewer infusions than Advate when used as prophylaxis to reduce the frequency of bleeding episodes.
“For more than 70 years, we’ve pioneered innovations and worked tirelessly to improve the standard of care for hemophilia patients,” Cherednichenko wrote in the letter to patients. “We are proud to offer alternative treatment options … that may meet your individual needs and are similar to Hemofil M and Recombinate.”
Takeda also is working with healthcare professionals and national member organizations belonging to the World Federation of Hemophilia (WFH) to help with the transition, according to a WFH statement. National member organizations needing support should reach out to their WFH regional manager.
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